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

    BETA/PAK

    K Number: K790769 · Decision May 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    37
    Review Days
    14

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    Basic Information

    Device Name
    BETA/PAK
    K Number
    K790769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bio/Data Corp.
    Date Received
    April 19, 1979
    Decision Date
    May 3, 1979
    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 Bio/Data Corp.

    K Number Device Name
    K001891 MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
    K943153 MICROSAMPLE COAGULATION ANALYZER
    K893650 PLATELET AGGREGATION PROFILER MODEL PAP-4C
    K881150 KINETIC FIBRINOGEN ASSAY
    K873382 PLATELET EXTRACT REAGENT
    K860751 VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
    K860342 MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
    K854546 MICROSAMPLE COAGULATION ANALYSER MODEL 110P
    K853897 CITREX H
    K853246 CALCIUM CHLORIDE
    Search all 37 clearances from Bio/Data Corp. →