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

    SOLUBLE COLLAGEN

    K Number: K780285 · Decision Mar 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    39
    Review Days
    37

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    Basic Information

    Device Name
    SOLUBLE COLLAGEN
    K Number
    K780285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    February 21, 1978
    Decision Date
    March 30, 1978
    Product Code
    JOZ
    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
    JOZ System, Automated Platelet Aggregation

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    Other Clearances by General Diagnostics

    K Number Device Name
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    K871305 COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
    K864993 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
    K863877 BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
    K842307 GENERAL DIAG. CEFONICID 30MCG ANTIMIC
    K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY
    K833709 CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
    K832653 CEFUROXIME 30MCG. SUSCEP DISK
    K831179 CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
    Search all 39 clearances from General Diagnostics →