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510(k) Data Aggregation

    K Number
    K971157
    Device Name
    MACRALP(A) ENZYME IMMUNOASSAY KIT
    Manufacturer
    STRATEGIC DIAGNOSTICS, INC.
    Date Cleared
    1998-04-15

    (383 days)

    Product Code
    JHODFC
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRATEGIC DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MACRA O LP (a) ENZYME The IN VITRO I mmuro solizant Assay (ELISA) kit is Fri CIAGNOSTIC the guartititive DEVICE FOR MIEASUILEMEN ASSESSment Ob SErum or plasma FOR CONCON ary heart 017EASE Risk OF F OLL )之:: SPECIFIC DORULLATIONS ALONG WITH Official FACTORS.
    Device Description
    IN VITRO I mmuro solizant Assay (ELISA) kit
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