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

    DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM

    K Number: K864230 · Decision Nov 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    253
    Review Days
    31

    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
    DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
    K Number
    K864230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    October 28, 1986
    Decision Date
    November 28, 1986
    Product Code
    CKE
    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
    CKE Acid Phosphatase, Thymolphthale Inmonophosphate

    Similar 510(k) Clearances

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

    CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACID PHOSPHATASE REAGENT SET

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

    Other Clearances by E.I. Dupont DE Nemours & Co., Inc.

    K Number Device Name
    K951851 ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
    K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE
    K953724 CRONEX RADIATION THERAPY CASSETTE
    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
    K950137 URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950136 URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950181 URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950135 URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950182 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →