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

    CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10

    K Number: K982062 · Decision Jan 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    20
    Review Days
    212

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    Basic Information

    Device Name
    CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
    K Number
    K982062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Biologicals, Inc.
    Date Received
    June 15, 1998
    Decision Date
    January 13, 1999
    Product Code
    GGW
    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
    GGW Test, Time, Partial Thromboplastin

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    Other Clearances by Precision Biologicals, Inc.

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    K971219 CRYO CHECK INR VALIDATION SET
    K971222 CRYO CHECK APC RESISTANT PLASMA
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    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
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