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

    CHOLORDE REAGENT

    K Number: K791690 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    18
    Applicant Total
    52
    Review Days
    48

    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
    CHOLORDE REAGENT
    K Number
    K791690
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hi Chem, Inc.
    Date Received
    July 31, 1979
    Decision Date
    September 17, 1979
    Product Code
    JFS
    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
    JFS Coulometric, Chloride

    Similar 510(k) Clearances

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

    CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REDI-CHECK PHOTMETER Q.A.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHLORIDE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REAGENTS CORNING CHLORIDE METER FOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RERMCO TEST CHLORIDE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIQUIZYME CHLORIDE REAGENT

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

    Other Clearances by Hi Chem, Inc.

    K Number Device Name
    K960084 HICHEM GLUCOSE/HK REAGENT KIT
    K951818 HICHEM ALT REAGENT KIT
    K943684 HICHEM ENZYME VERIFIER KIT
    K941764 HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
    K902673 HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
    K863617 ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
    K862027 LDP REAGENT CARTRIDGE (NO. 88216)
    K861893 GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
    K861879 CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
    K861284 AP REAGENT CARTRIDGE
    Search all 52 clearances from Hi Chem, Inc. →