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

    RABBIT ANTI-HUMAN ANTITHROMBIN III

    K Number: K832268 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    14
    Review Days
    43

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    Basic Information

    Device Name
    RABBIT ANTI-HUMAN ANTITHROMBIN III
    K Number
    K832268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gelco Diagnostics, Inc.
    Date Received
    June 30, 1983
    Decision Date
    August 12, 1983
    Product Code
    JBQ
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JBQ Antithrombin Iii Quantitation

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    Other Clearances by Gelco Diagnostics, Inc.

    K Number Device Name
    K832267 FITC GOAT ANTI-HUMAN LAMBA
    K832262 FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
    K832263 FITC GOAT ANTI-HUMAN IGA A CHAIN
    K832258 GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
    K832256 GOAT ANTI-HUMAN IMMUNOGLOBULINS-
    K832270 GOAT ANTI-HUMAN LAMBA
    K832260 GOAT ANTI-HUMAN KAPPA AFFINITY
    K832266 FITC GOAT ANTI-HUMAN KAPPA AFFINITY
    K832265 FITC GOAT ANTI-HUMAN IGM H CHAIN
    K832257 GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC
    Search all 14 clearances from Gelco Diagnostics, Inc. →