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

    LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

    K Number: K953927 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    7
    Review Days
    31

    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
    LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
    K Number
    K953927
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Enzymes, Inc.
    Date Received
    August 15, 1995
    Decision Date
    September 15, 1995
    Product Code
    DCF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DCF Albumin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Optilite Low Level Albumin Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Human Microalbumin kit for use on SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Urine/CSF Albumin, Urine/CSF Albumin Calibrator

    FDA 510(k)
    FDA Class 2 ·Immunology

    HUMAN ALBUMIN CSF KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT ALBUMIN GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by International Enzymes, Inc.

    K Number Device Name
    K011169 HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
    K963085 LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
    K953926 LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
    K950802 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
    K944486 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
    K944513 LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E