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

    RAPID FERMENTATION AGAR (RFA)

    K Number: K800734 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    52
    Applicant Total
    137
    Review Days
    36

    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
    RAPID FERMENTATION AGAR (RFA)
    K Number
    K800734
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Remel Co.
    Date Received
    April 2, 1980
    Decision Date
    May 8, 1980
    Product Code
    JSE
    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
    JSE Culture Media, Multiple Biochemical Test

    Similar 510(k) Clearances

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

    MLX MICROTITER PLATE LUMINOMETER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    X-ACT UREA/TDA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    X-ACT LDC/IND

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MIL MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MRVP BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR

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

    Other Clearances by Remel Co.

    K Number Device Name
    K013711 BACTI-SWAB DRY
    K965150 A.C.T. IV
    K965151 A.C.T. III
    K965152 A.C.T. II
    K965149 A.C.T. I
    K960090 CALCOFLUOR WHITE STAIN KIT
    K960095 BACTIDROP CALCOFLUOR WHITE
    K955669 REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
    K941443 SYNERGY QUAD
    K941444 BHI AGAR WITH VANCOMYCIN
    Search all 137 clearances from Remel Co. →