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

    FETAL MATURITY TEST PROCEDURE

    K Number: K790798 · Decision Jun 5, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    280
    Review Days
    49

    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
    FETAL MATURITY TEST PROCEDURE
    K Number
    K790798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1455
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    April 17, 1979
    Decision Date
    June 5, 1979
    Product Code
    JHG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    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

    AMNIO STAT-FLM AGGLUTINATION TEST

    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
    View all

    Other Clearances by Helena Laboratories

    K Number Device Name
    K131479 V8 SP NORMAL CONTROL, ABNORMAL CONTROL
    K100103 SPECIALTY ASSAYED CONTROL-2
    K061991 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
    K061069 SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
    K061014 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
    K050053 HEMORAM/AGGRAM ANALYZER
    K024162 SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
    K023761 PLATELETWORKS, MODELS PW-A, PW-C
    K022757 SPIFE CK KIT, MODEL 3332, 3333
    K022455 SPIFE LD-12 KIT, MODEL 3338
    Search all 280 clearances from Helena Laboratories →