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

    APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1

    K Number: K853048 · Decision Aug 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    12
    Review Days
    40

    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
    APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
    K Number
    K853048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Photec Diagnostics, Inc.
    Date Received
    July 19, 1985
    Decision Date
    August 28, 1985
    Product Code
    DER
    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
    DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    TINA-QUANT APOLIPOPROTEIN VER.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    BAYER ADVIA IMS SYSTEM; 200 + 3

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY APO B

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY APO AI

    FDA 510(k)
    FDA Class 2 ·Immunology

    INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1

    FDA 510(k)
    FDA Class 2 ·Immunology

    APOLIPOPROTEIN A1

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

    Other Clearances by Photec Diagnostics, Inc.

    K Number Device Name
    K897169 QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
    K896329 D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
    K894057 QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
    K892224 D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
    K890267 QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
    K890027 QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD
    K882307 D-CHEM
    K880291 THEOPHYLLINE TEST KIT REF. #A874799
    K854875 APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1
    K853174 APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
    Search all 12 clearances from Photec Diagnostics, Inc. →