BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT

    K Number: K883333 · Decision Aug 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    26
    Review Days
    16

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
    K Number
    K883333
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2160
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immuno-Mycologics, Inc.
    Date Received
    August 9, 1988
    Decision Date
    August 25, 1988
    Product Code
    JTL
    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
    JTL Plasma, Coagulase, Human, Horse And Rabbit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JTL), ordered by most recent decision date.

    DRYSLIDE COAGULASE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LYFO-KWIK (TM) COAGULASE PLASMA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HEMASTAPH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    API STAPHASE III

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COAGULASE PLASMA, HORSE & RABBIT EDTA

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Immuno-Mycologics, Inc.

    K Number Device Name
    K120946 ALPHA CRYPTOCOCCAL ANTIGEN EIA
    K112422 CRAG LATERAL FLOW ASSAY (LFA)
    K102286 CRAG LATERAL FLOW ASSAY (CRAG LFA)
    K101407 ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
    K880029 EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
    K843286 EI-CANDIDA ENZYME IMMUNOASSAY EI1001
    K831918 LA-STAPH IDENTIFICATION SYSTEM
    K830837 LA-HISTO ANTIBODY SYSTEM #HL 1001
    K810510 YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
    K802427 LA-SPORO ANTIBODY SYSTEM
    Search all 26 clearances from Immuno-Mycologics, Inc. →