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510(k) Data Aggregation

    K Number
    K965169
    Device Name
    STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
    Manufacturer
    SPECIALIZED ASSAYS, INC.
    Date Cleared
    1997-02-06

    (44 days)

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

    SPECIALIZED ASSAYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K965166
    Device Name
    STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
    Manufacturer
    SPECIALIZED ASSAYS, INC.
    Date Cleared
    1997-02-04

    (42 days)

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

    SPECIALIZED ASSAYS, INC.

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

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    K Number
    K965168
    Device Name
    STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
    Manufacturer
    SPECIALIZED ASSAYS, INC.
    Date Cleared
    1997-02-04

    (42 days)

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

    SPECIALIZED ASSAYS, 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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