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

    JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT

    K Number: K925468 · Decision Apr 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    529

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    Basic Information

    Device Name
    JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT
    K Number
    K925468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    J.J. Skinner, Inc.
    Date Received
    October 29, 1992
    Decision Date
    April 11, 1994
    Product Code
    GJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GJE Tray, Blood Collection

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    Other Clearances by J.J. Skinner, Inc.

    K Number Device Name
    K961227 JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY
    K961683 JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
    K925469 JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
    K925467 JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT
    K903545 CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
    K903544 CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS