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

    SHIGELLA I.D.

    K Number: K821337 · Decision May 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    40
    Applicant Total
    57
    Review Days
    23

    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
    SHIGELLA I.D.
    K Number
    K821337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Products, Inc.
    Date Received
    May 5, 1982
    Decision Date
    May 28, 1982
    Product Code
    GNB
    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
    GNB Antisera, All Types, Shigella Spp.

    Similar 510(k) Clearances

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

    SAS SHIGELLA SONNEI FORM II ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS SHIGELLA BOYDII TYPE 15 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM

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

    Other Clearances by Analytical Products, Inc.

    K Number Device Name
    K924814 API 20E/UNISCEPT 20E
    K923684 API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
    K922926 API UNISCEPT KB/TYPE 2 AND 3
    K901559 MODIFICATION TO API UNISCEPT 20GP
    K901390 DMAC INDOLE REAGENT
    K895796 API UNISCEPT KB
    K884510 MODIFICATION MICRO-MIC
    K884509 MODIFICATION MIC/API UNISCEPT(R)
    K880598 MODIFICATIONS TO API UNISCEPT (R) KB
    K874466 API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
    Search all 57 clearances from Analytical Products, Inc. →