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

    UIBC FOR DISCREET RANDOM ACCESS ANALYZER

    K Number: K932871 · Decision Sep 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    20
    Applicant Total
    41
    Review Days
    86

    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
    UIBC FOR DISCREET RANDOM ACCESS ANALYZER
    K Number
    K932871
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catachem, Inc.
    Date Received
    June 14, 1993
    Decision Date
    September 8, 1993
    Product Code
    CFM
    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
    CFM Bathophenanthroline, Colorimetry, Iron (Non-Heme)

    Similar 510(k) Clearances

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

    WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IRON

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ABBOTT QLUICKSTART IRON TEST, ITEM #5A29

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNERMED SERUM IRON-600 REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNERMED SERUM IRON REAGENT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CLINISTAT POTASSIUM REAGENT TEST

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

    Other Clearances by Catachem, Inc.

    K Number Device Name
    K062503 CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
    K945408 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
    K903341 MAGNESIUM
    K902326 AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
    K902877 TOTAL IRON FOR MANUAL/AUTOMATED
    K895748 BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
    K895821 URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
    K894715 CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
    K894389 CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
    K894476 CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
    Search all 41 clearances from Catachem, Inc. →