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

    IDS RAPIDS NH SYSTEMS

    K Number: K812048 · Decision Aug 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    24
    Review Days
    29

    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
    IDS RAPIDS NH SYSTEMS
    K Number
    K812048
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Carr-Scarborough Microbiologicals, Inc.
    Date Received
    July 20, 1981
    Decision Date
    August 18, 1981
    Product Code
    JSX
    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
    JSX Kit, Identification, Neisseria Gonorrhoeae

    Similar 510(k) Clearances

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

    GONOPOX TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NIZYME TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VISI-NEISSERIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    XACT NEISSERIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFIED IDS RAPID NH SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST

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

    Other Clearances by Carr-Scarborough Microbiologicals, Inc.

    K Number Device Name
    K944554 BRAIN HEART INFUSION AGAR
    K941985 MUELLER HINTON AGAR W/OXACILLIN
    K905472 LAP DISCS
    K905666 M. CAT. BUTYRATE DISC
    K891476 C. ALBICANS SCREEN
    K882630 PRO DISCS
    K882636 ALN DISCS
    K863216 NEIS NZY
    K860301 RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
    K860302 PYR DISCS
    Search all 24 clearances from Carr-Scarborough Microbiologicals, Inc. →