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510(k) Data Aggregation

    K Number
    K001177
    Device Name
    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
    Manufacturer
    ENTERIC PRODUCTS, INC.
    Date Cleared
    2000-11-13

    (216 days)

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

    ENTERIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984544
    Device Name
    THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
    Manufacturer
    ENTERIC PRODUCTS, INC.
    Date Cleared
    1999-02-18

    (58 days)

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

    ENTERIC PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test for the detection of IgG antibodies in serum or plasma in adult symptomatic patients which is intended for professional in-vitro use as an adjunct or aid in the diagnosis of Helicobacter pylori.
    Device Description
    Not Found
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