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

    TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY

    K Number: K972640 · Decision Jan 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    340
    Review Days
    178

    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
    TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
    K Number
    K972640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    July 15, 1997
    Decision Date
    January 9, 1998
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

    FDA 510(k)
    FDA Class 2 ·Immunology

    N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTIA A1-AT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

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

    Other Clearances by Boehringer Mannheim Corp.

    K Number Device Name
    K984326 ELECYS IGE ASSAY
    K983047 ACCU-CHEK HQ SYSTEM
    K984419 ELECSYS IGE CALCHECK
    K984425 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
    K984372 ELECSYS CALCHECK TROPONIN T
    K984105 ELECSYS TROPONIN T STAT TEST
    K983503 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
    K983469 PRECISET SERUM PROTEINS CALIBRATOR
    K983185 BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
    K982949 ELECSYS PSA, MODEL 2010
    Search all 340 clearances from Boehringer Mannheim Corp. →