BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

    K Number: K001177 · Decision Nov 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    216

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    Basic Information

    Device Name
    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
    K Number
    K001177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Enteric Products, Inc.
    Date Received
    April 11, 2000
    Decision Date
    November 13, 2000
    Product Code
    LYR
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYR Helicobacter Pylori

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    Other Clearances by Enteric Products, Inc.

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    K984544 THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S