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

    GEMINII GAMMA COUNTER

    K Number: K882194 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    4
    Review Days
    71

    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
    GEMINII GAMMA COUNTER
    K Number
    K882194
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Technologies, Inc.
    Date Received
    May 25, 1988
    Decision Date
    August 4, 1988
    Product Code
    JJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    Similar 510(k) Clearances

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

    Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION EXL WITH LM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT

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

    Other Clearances by Laboratory Technologies, Inc.

    K Number Device Name
    K921536 ACCULYTE CHEMILUMINESCENCE ANALYZER
    K900087 GENESYS 6000 GAMMA COUNTER
    K851689 GENESYS GAMMA COUNTER