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

    BACTIGEN - N.MENNINIGITIDIS TEST

    K Number: K841907 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    68
    Review Days
    59

    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
    BACTIGEN - N.MENNINIGITIDIS TEST
    K Number
    K841907
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    May 8, 1984
    Decision Date
    July 6, 1984
    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

    IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WELLCOGEN BACTERIAL ANTIGEN KIT

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

    Other Clearances by Armkel, LLC

    K Number Device Name
    K040866 FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
    K030258 FIRST RESPONSE PREGNANCY TEST
    K023405 TROJAN MINT TINGLE BRAND LATEX CONDOMS
    K013433 TROJAN PASSION BERRY GEL
    K013614 TROJAN CRYSTAL CLEAR LIQUID
    K001212 TROJAN EXTRA LARGE LATEX CONDOM
    K000748 TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
    K992232 FIRST RESPONSE 1-STEP PREGNANCY
    K973352 BRAND NAME *1-STEP PREGNANCY
    K973310 TBD* ONE-STEP OVULATION PREDICTOR TEST
    Search all 68 clearances from Armkel, LLC →