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

    ANALYZER, IMPACT 100

    K Number: K790073 · Decision Feb 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    16
    Review Days
    42

    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
    ANALYZER, IMPACT 100
    K Number
    K790073
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2500
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gilford Instrument Laboratories, Inc.
    Date Received
    January 11, 1979
    Decision Date
    February 22, 1979
    Product Code
    JJI
    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
    JJI Analyzer, Enzyme, For Clinical Use

    Similar 510(k) Clearances

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

    CODA AUTOMATED EIA ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ABBOTT IMX 2 ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ABBOTT IMX2 ANALYER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RADIAS AUTOMATED IMMUNOASSAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUICKRATE REACTION RATE ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MINISTAT-S CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Gilford Instrument Laboratories, Inc.

    K Number Device Name
    K823233 SBA 300 CLINICAL CHEMISTRY ANALYZER
    K821583 AMES/GILFORD OPTIMATE CLIN. CHEM & THER
    K802609 CHEMISTRY ANALYZER IMPACT 400
    K801889 MODEL 203S CLINICAL CHEMISTRY ANALYZER
    K800085 SYSTEM 203 CHEMISTRY ANALYZER
    K792361 SYSTEM 103 CHEMISTRY ANALYZER
    K792087 MICROFLAME PHOTOMETER
    K791968 EIA (ELISA) READER
    K790072 ANALYZER, IMPACT 200
    K781269 ELISA SYSTME
    Search all 16 clearances from Gilford Instrument Laboratories, Inc. →