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

    MEASLES-FA LABELLED (8-441 RF)

    K Number: K770805 · Decision May 20, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    57
    Review Days
    17

    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
    MEASLES-FA LABELLED (8-441 RF)
    K Number
    K770805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Flow Laboratories, Inc.
    Date Received
    May 3, 1977
    Decision Date
    May 20, 1977
    Product Code
    GOL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GOL Antigen, Ha (Including Ha Control), Rubella

    Similar 510(k) Clearances

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

    RUBELLA ANTIBODY FLUOROIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBAQUICK DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBELLA ANTIBODIES TEST REAGENTS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EIA RUBELLA-G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBELISA IGM TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Flow Laboratories, Inc.

    K Number Device Name
    K861897 UNISKAN II
    K862066 TITERTEK MICROPLATE WASHER S-12
    K861823 GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
    K861824 GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
    K861791 PENICILLIN-STREPTOMYCIN-FUNGIZONE
    K860752 GOAT SERUM (29-391-54)
    K860762 GAMMA-FREE HORSE SERUM
    K850908 TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
    K844418 TITERTEK MULTISKAN MCC
    K844419 TITERTEK MULTISKAN MSS/340
    Search all 57 clearances from Flow Laboratories, Inc. →