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

    HYGEIA GC TEST

    K Number: K881064 · Decision Jun 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    80

    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
    HYGEIA GC TEST
    K Number
    K881064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hygeia Sciences
    Date Received
    March 14, 1988
    Decision Date
    June 2, 1988
    Product Code
    LIR
    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
    LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae

    Similar 510(k) Clearances

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

    GC OIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL

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

    Other Clearances by Hygeia Sciences

    K Number Device Name
    K882192 HYGEIA URINE PREGNANCY TEST
    K862083 HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
    K862133 HYGEIA RAPID STREP A TEST