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

    SCLAVO CHLORIDE TEST

    K Number: K843740 · Decision Oct 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    52
    Applicant Total
    82
    Review Days
    10

    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
    SCLAVO CHLORIDE TEST
    K Number
    K843740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    September 25, 1984
    Decision Date
    October 5, 1984
    Product Code
    CHJ
    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
    CHJ Mercuric Thiocyanate, Colorimetry, Chloride

    Similar 510(k) Clearances

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

    PICCOLO CHLORIDE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHLORIDE QVET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS CHLORIDE REAGENT, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS CHLORID REAGENT, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OLYMPUS CHLORIDE REAGENT

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

    Other Clearances by Sclavo, Inc.

    K Number Device Name
    K914789 ELISA CMV IGM
    K914852 ELISA TOXO IGM
    K914420 ELISA RUBELLA IGM
    K895943 NORMAL AND ABNORMAL CONTROL SERA
    K895822 TOTAL BILIRUBIN L.F.
    K895847 CREATININE 340 (ENZYMATIC)
    K880049 CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
    K880199 CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
    K873496 ATYPICAL CHOLINESTERASE
    K884035 SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
    Search all 82 clearances from Sclavo, Inc. →