BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50

    K Number: K023990 · Decision Mar 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    10
    Review Days
    106

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    Basic Information

    Device Name
    CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
    K Number
    K023990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Biologic
    Date Received
    December 3, 2002
    Decision Date
    March 19, 2003
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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    Other Clearances by Precision Biologic

    K Number Device Name
    K193556 Cryocheck Hex LA
    K193204 Cryocheck Chromogenic Factor VIII
    K032804 CRYOCHECK WEAK LUPUS POSITIVE CONTROL
    K023991 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
    K013708 REFERENCE CHECK, CATALOG NUMBER-RCN-10
    K990580 CRYOCHECK LA SURE, MODEL SUR25-10
    K990579 CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
    K990814 CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
    K990296 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)