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

    URINARY ALBUMIN CALIBRATOR

    K Number: K936201 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    129
    Applicant Total
    28
    Review Days
    72

    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
    URINARY ALBUMIN CALIBRATOR
    K Number
    K936201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dupont Medical Products
    Date Received
    December 29, 1993
    Decision Date
    March 11, 1994
    Product Code
    JIS
    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
    JIS Calibrator, Primary

    Similar 510(k) Clearances

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

    DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION IRON CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

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

    Other Clearances by Dupont Medical Products

    K Number Device Name
    K952815 DUPONT LIPASE CALIBRATOR
    K950920 DUPONT DIMENSION TOTAL PROTEIN METHOD
    K952816 LIPASE FLEX REAGENT CARTRIDGE
    K952412 DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
    K945280 DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
    K944932 PHENOBARBITAL FLEX REAGENT CARTRIDGE
    K941050 DUPONT ACA STAR
    K943996 DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
    K941146 DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
    K942640 DUPONT DIMENSION AMYLASE METHOD
    Search all 28 clearances from Dupont Medical Products →