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

    IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

    K Number: K802128 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    53

    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
    IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
    K Number
    K802128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3060
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Nolan Biological Laboratories, Inc.
    Date Received
    August 4, 1980
    Decision Date
    September 26, 1980
    Product Code
    JWW
    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
    JWW Antigen, Cf, B. Dermatitidis

    Similar 510(k) Clearances

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

    BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BLASTOMYCES DERMATITIDIS, ANTIGEN

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

    Other Clearances by Nolan Biological Laboratories, Inc.

    K Number Device Name
    K812741 REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
    K812740 REAGENTS FOR SERODIAGNOSIS OF ASPERGILL
    K802129 IMMUNODIFFUSION REAGENTS/SEROLOGICAL
    K802130 IMMUNO. IDENTIFICATION OF H. CAPSULATUM