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

    MICRO-ID

    K Number: K760790 · Decision Oct 29, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    39
    Review Days
    22

    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
    MICRO-ID
    K Number
    K760790
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    October 7, 1976
    Decision Date
    October 29, 1976
    Product Code
    JSS
    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
    JSS Kit, Identification, Enterobacteriaceae

    Similar 510(k) Clearances

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

    hemoFISH Masterpanel

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GRAM-NEGATIVE QUICKFISH BC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GNR TRAFFIC LIGHT PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    E.COLI/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EK/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    E. COLI PNA FISH

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

    Other Clearances by General Diagnostics

    K Number Device Name
    K882663 BARBITURATE ENZYME IMMUNOASSAY KIT
    K872882 CANNABINOID ENZYME IMMUNOASSAY KIT
    K871305 COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
    K864993 QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
    K863877 BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
    K842307 GENERAL DIAG. CEFONICID 30MCG ANTIMIC
    K841465 GENERAL DIAGNOSTICS PLATELET ANTIBODY
    K833709 CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK
    K832653 CEFUROXIME 30MCG. SUSCEP DISK
    K831179 CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
    Search all 39 clearances from General Diagnostics →