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

    QM300 CONTROL F PACK

    K Number: K883712 · Decision Sep 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    42
    Applicant Total
    58
    Review Days
    23

    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
    QM300 CONTROL F PACK
    K Number
    K883712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    August 30, 1988
    Decision Date
    September 22, 1988
    Product Code
    DFC
    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
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Lipoprotein (a) Molarity Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    Tina-quant Lipoprotein(a) Gen.2 Molarity

    FDA 510(k)
    FDA Class 2 ·Immunology

    Lp(a) Ultra

    FDA 510(k)
    FDA Class 2 ·Immunology

    Diazyme Lipoprotein (a) Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

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

    Other Clearances by Kallestad Diag, A Div. of Erbamont, Inc.

    K Number Device Name
    K910885 QM300 CALIBRATOR G PACK
    K910887 QM300 CONTROL G PACK
    K910886 QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
    K904725 CHLAMYDIA SYSTEM SOFTWARE (CSS)
    K902253 PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
    K902462 MODIFIED QM300 RHEUMATOID FACTOR TEST
    K900010 NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
    K900009 NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
    K897072 NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
    K894947 PLATELIA TOXO IGG KIT
    Search all 58 clearances from Kallestad Diag, A Div. of Erbamont, Inc. →