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510(k) Data Aggregation

    K Number
    K011952
    Device Name
    DRUGS OF ABUSE MULTI-TEST STRIP
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    2001-10-25

    (126 days)

    Product Code
    DKZ, DIO, DJD, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.
    Device Description
    Not Found
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    K Number
    K991505
    Device Name
    MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1999-08-05

    (98 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.
    Device Description
    Not Found
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    K Number
    K991516
    Device Name
    MICRO-STRIP FOR MARIJUANA METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1999-08-05

    (97 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/m1. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.
    Device Description
    Not Found
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    K Number
    K981388
    Device Name
    MICRO-STRIP FOR COCAINE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1998-05-29

    (43 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microdiagnostics, Inc. Micro-Strip for Cocaine Metabolites is intended to qualitatively detect the metabolites of cocaine in urine at the SAMHSA/NIDA cutoff limit of 300 ng/ml.
    Device Description
    Not Found
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    K Number
    K974611
    Device Name
    MICRO-STRIP FOR AMPHETAMINE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1998-03-20

    (99 days)

    Product Code
    DKZ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.
    Device Description
    Not Found
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    K Number
    K973761
    Device Name
    MICRO-STRIP FOR OPIATE METABOLITES
    Manufacturer
    MICRODIAGNOSTICS, INC.
    Date Cleared
    1997-12-24

    (83 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRODIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.
    Device Description
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