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

    RPR CARD TEST KIT

    K Number: K955136 · Decision Jul 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    259

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    Basic Information

    Device Name
    RPR CARD TEST KIT
    K Number
    K955136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remel, L.P.
    Date Received
    November 13, 1995
    Decision Date
    July 29, 1996
    Product Code
    GMQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GMQ Antigens, Nontreponemal, All

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    Other Clearances by Remel, L.P.

    K Number Device Name
    K972359 REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
    K964315 REMEL STAPH LATEX KIT
    K964421 REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
    K961046 10B ARGININE BROTH
    K955143 RPR LIQUID CONTROLS
    K961818 GENTAMICIN DISK (120MCG)
    K961819 STREPTOMYCIN DISK (300MCG)
    K960313 MUELLER HINTON AGAR WITH 2% NACI
    K954986 GC BASE W/ 1% GCHI