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

    GAMMA SLIDE TEST FOR PREGNANCY

    K Number: K832473 · Decision Aug 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    95
    Applicant Total
    21
    Review Days
    21

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    Basic Information

    Device Name
    GAMMA SLIDE TEST FOR PREGNANCY
    K Number
    K832473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    July 26, 1983
    Decision Date
    August 16, 1983
    Product Code
    JHJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHJ Agglutination Method, Human Chorionic Gonadotropin

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    Other Clearances by Gamma Biologicals, Inc.

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    K813342 GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
    K820072 FE-CULT PLUS
    K811752 FE-CULT PLUS
    K802533 GAMMA LEWIS BLOOD GROUP SUBSTANCE
    K802534 GAMMA PI BLOOD GROUP SUBSTANCE
    K800658 RST-SERIES CONTROL
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