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

    ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT

    K Number: K971458 · Decision Sep 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    133

    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
    ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
    K Number
    K971458
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1645
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Specialties
    Date Received
    April 22, 1997
    Decision Date
    September 2, 1997
    Product Code
    JIQ
    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
    JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

    Similar 510(k) Clearances

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

    TOTAL PROTEIN URINE/CSF GEN.3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AUSAM TOTAL ALBUMIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMOCHEK URINE COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URINARY ALBUMIN TEST PACK

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

    Other Clearances by Diagnostic Specialties

    K Number Device Name
    K941001 ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
    K930823 PROTEIN-BOUND GLUCOSE ASSAYN KIT
    K922032 ENZIP URINARY MICROALBUMIN TEST
    K831180 PREGNA-CERT, SLIDE PREGNANCY TEST
    K823109 GENERIC PREGNANCY TEST
    K813608 POTASSIUM REAGENT SET
    K813412 GLUCOSE ENZYME-COLOR REAGENT SET