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510(k) Data Aggregation

    K Number
    K000116
    Device Name
    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    2000-02-15

    (32 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992576
    Device Name
    URINE CHEMISTRY CONTROL, LEVEL 1
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1999-09-03

    (32 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
    Device Description
    Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.
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    K Number
    K992578
    Device Name
    URINE CHEMISTRY CONTROL, LEVEL 2
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1999-09-03

    (32 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urine Chemistry Control, Level 2, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
    Device Description
    Urine Chemistry Control. Level 2, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 2 will be offered in 10.0 mL and 25.0 mL fill vials.
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    K Number
    K992151
    Device Name
    REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1999-07-14

    (20 days)

    Product Code
    LAS
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.
    Device Description
    Reference Material for Delta-9-THC-COOH in Human Urine
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    K Number
    K981339
    Device Name
    QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1998-04-21

    (8 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
    Device Description
    QUICKCHECK Lyophilized Chemistry Control Also Distributed as: CONFORMANCE® Chemistry Control C3
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    K Number
    K974699
    Device Name
    REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1998-01-22

    (37 days)

    Product Code
    DKB
    Regulation Number
    862.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.
    Device Description
    Reference Material for Amphetamine/Methamphetamine in Human Urine
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    K Number
    K973469
    Device Name
    QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1997-09-25

    (21 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clinical laboratories performing chemistry assays may use huve mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c ) above mentioned controls are validated for use with the specific clinical chemistry test system used by the laboratory.
    Device Description
    QUIKCHECK Unassayed Chemistry Control Levels 1 and 2
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    K Number
    K972146
    Device Name
    QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1997-07-08

    (29 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used: (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.
    Device Description
    Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)
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    K Number
    K972080
    Device Name
    QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1997-06-18

    (15 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems. (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals; (c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory. These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
    Device Description
    Not Found
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    K Number
    K961815
    Device Name
    QUALITROL ANA CONTROL SERUM SET
    Manufacturer
    CONSOLIDATED TECHNOLOGIES, INC.
    Date Cleared
    1996-09-27

    (140 days)

    Product Code
    LKJ
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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