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

    IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

    K Number: K870089 · Decision Mar 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    11
    Review Days
    67

    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
    IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
    K Number
    K870089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microscan Div. Baxter Healthcare Corp.
    Date Received
    January 9, 1987
    Decision Date
    March 17, 1987
    Product Code
    GTJ
    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
    GTJ Antisera, All Groups, N. Meningitidis

    Similar 510(k) Clearances

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

    DIRECTIGEN MENINGITIS COMBO TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIRECTIGEN MENINGITIS COMBO TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SLIDEX MENINGITE-KIT 5

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BACTIGEN(R) N. MENINGITIDIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WELLCOGEN BACTERIAL ANTIGEN KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

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

    Other Clearances by Microscan Div. Baxter Healthcare Corp.

    K Number Device Name
    K871232 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
    K871231 ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
    K871228 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
    K871230 ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
    K871233 ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
    K871229 ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
    K871234 ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
    K870814 HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
    K870074 GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
    K871033 RABBIT KIDNEY CULTURE CELLS (FIRST PASS)
    Search all 11 clearances from Microscan Div. Baxter Healthcare Corp. →