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

    CRYO CHECK FACTOR V DEFICIENT PLASMA

    K Number: K971223 · Decision Jul 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    78
    Applicant Total
    20
    Review Days
    111

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CRYO CHECK FACTOR V DEFICIENT PLASMA
    K Number
    K971223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Precision Biologicals, Inc.
    Date Received
    April 2, 1997
    Decision Date
    July 22, 1997
    Product Code
    GJT
    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
    GJT Plasma, Coagulation Factor Deficient

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GJT), ordered by most recent decision date.

    CRYOcheck Factor VIII Deficient Plasma with VWF

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL Factor XII Deficient Plasma

    FDA 510(k)
    FDA Class 2 ·Hematology

    NOFACT IX

    FDA 510(k)
    FDA Class 2 ·Hematology

    NOFACT VIII

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL FACTOR VIII DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSIL FACTOR II DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Precision Biologicals, Inc.

    K Number Device Name
    K981173 CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
    K982062 CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
    K981174 CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
    K971219 CRYO CHECK INR VALIDATION SET
    K971222 CRYO CHECK APC RESISTANT PLASMA
    K971227 CRYO CHECK FACTOR X DEFICIENT PLASMA
    K971226 CRYO CHECK FACTOR IX DEFICIENT PLASMA
    K971225 CRYO CHECK FACTOR VIII DEFICIENT PLASMA
    K971224 CRYO CHECK FACTOR VII DEFICIENT PLASMA
    K951823 CRYO CHECK LOW FIBRINOGEN CONTROL
    Search all 20 clearances from Precision Biologicals, Inc. →