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

    VACUPLUS TUBES WITH GREY STOPPERS

    K Number: K924364 · Decision Mar 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    11
    Review Days
    185

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    Basic Information

    Device Name
    VACUPLUS TUBES WITH GREY STOPPERS
    K Number
    K924364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Starplex Scientific, Inc.
    Date Received
    August 28, 1992
    Decision Date
    March 1, 1993
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Starplex Scientific, Inc.

    K Number Device Name
    K032246 MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    K022388 STARTOX DRUG OF ABUSE SCREENING TEST (4)
    K021006 STARTOX DRUG OF ABUSE SCREENING TEST
    K962843 MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    K960997 STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
    K944847 KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM
    K924361 VACUPLUS TUBES WITH GREEN STOPPERS
    K924362 VACUPLUS TUBES WITH LAVANDER STOPPERS
    K924363 VACUPLUS(R) STAR-SEP(TM)
    K924365 VACUPLUS TUBES WITH BRICK RED STOPPERS
    Search all 11 clearances from Starplex Scientific, Inc. →