BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIPSTICK SALMONELLA

    K Number: K910438 · Decision Sep 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    68
    Applicant Total
    15
    Review Days
    225

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    Basic Information

    Device Name
    DIPSTICK SALMONELLA
    K Number
    K910438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3550
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ampcor, Inc.
    Date Received
    January 31, 1991
    Decision Date
    September 13, 1991
    Product Code
    GRM
    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
    GRM Antisera, All Groups, Salmonella Spp.

    Similar 510(k) Clearances

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    SAS SALMONELLA O FACTOR 14 ANTISERUM

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    SAS SALMONELLA H Z42 ANTISERUM

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    SAS SALMONELLA H Z4, Z24 ANTISERUM

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    SAS SALMONELLA O FACTOR 20 ANTISERUM

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    Other Clearances by Ampcor, Inc.

    K Number Device Name
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    K922296 IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
    K893873 SINGLE AND DUAL BAND DIPSTICK HCG TEST
    K890048 QUIK-DOT TOXOPLASMOSIS
    K892146 C REACTIVE PROTEIN LIQUID
    K892119 QUIK-DOT C REACTIVE PROTEIN
    K890025 QUIK-DOT ANTISTREPTOLYSIN-O
    K884750 GROUP A STREP, BETA-STREP
    K880163 PREGNANCY (HCG) CARD & LIQUID TEST
    K880478 PREGNANCY BETA-HCG CARD & LIQUID TEST
    Search all 15 clearances from Ampcor, Inc. →