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510(k) Data Aggregation

    K Number
    K964278
    Device Name
    WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
    Date Cleared
    1996-11-22

    (25 days)

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

    CLINICAL CONTROLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962432
    Device Name
    LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
    Date Cleared
    1996-07-05

    (11 days)

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

    CLINICAL CONTROLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955690
    Device Name
    AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
    Date Cleared
    1996-04-24

    (132 days)

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

    CLINICAL CONTROLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955691
    Device Name
    SERUM VOLATILES CONTROL LEVEL 1 & 2
    Date Cleared
    1996-04-24

    (132 days)

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

    CLINICAL CONTROLS, INC.

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

    Ask a specific question about this device

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