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

    RPR LIQUID CONTROLS

    K Number: K955143 · Decision Jul 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    10
    Review Days
    260

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    Basic Information

    Device Name
    RPR LIQUID CONTROLS
    K Number
    K955143
    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 30, 1996
    Product Code
    GMP
    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
    GMP Antisera, Control For Nontreponemal Tests

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    Other Clearances by Remel, L.P.

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    K961818 GENTAMICIN DISK (120MCG)
    K961819 STREPTOMYCIN DISK (300MCG)
    K960313 MUELLER HINTON AGAR WITH 2% NACI
    K954986 GC BASE W/ 1% GCHI