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

    RUBELLA HEMAGGLUTINATION REAGENT KIT

    K Number: K771957 · Decision Oct 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    57
    Review Days
    11

    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
    RUBELLA HEMAGGLUTINATION REAGENT KIT
    K Number
    K771957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Flow Laboratories, Inc.
    Date Received
    October 17, 1977
    Decision Date
    October 28, 1977
    Product Code
    GOK
    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
    GOK Antisera, Hai (Including Hai Control), Rubella

    Similar 510(k) Clearances

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

    RUBASCAN LATEX CARD TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBAZYME - M

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ANTIBODY TO RUBELLA VIRUS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBELISA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBANON

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RUBINDEX*DIRECT SYSTEM

    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. →