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

    AMNIO STAT-FLM AGGLUTINATION TEST

    K Number: K834616 · Decision May 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    163

    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
    AMNIO STAT-FLM AGGLUTINATION TEST
    K Number
    K834616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1455
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    December 14, 1983
    Decision Date
    May 25, 1984
    Product Code
    JHG
    Advisory Committee
    Clinical Chemistry
    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
    JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio

    Similar 510(k) Clearances

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

    AMNIOSTAT-FLM-PG

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TDXR FETAL LUNG MATURITY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMNISTAT-FLM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SECURE FDI TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HELENA FETAL-TEK 200 METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FETAL MATURITY TEST PROCEDURE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Hana Biologics, Inc.

    K Number Device Name
    K883682 CHANG MEDIUM (ADDITIONAL INDICATIONS)
    K855205 MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
    K833933 ACE COLOR TEST
    K822736 MYCOTRIUM-GU
    K822737 MYCOTRIUM-RS
    K822150 AMNISTAT-FLM
    K812820 CHANG MEDIUM