FDA 510(k) Applications for Medical Device Product Code "DER"
(Alpha-1-Lipoprotein, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983289 ABBOTT LABORATORIES APOLIPOPROTEIN A1 01/29/1999
K000921 BAYER CORP. BAYER ADVIA IMS SYSTEM; 200 + 3 05/18/2000
K964292 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA APO A1 TEST KIT 08/01/1997
K964294 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA APO A1/B MULTI CALIBRATOR 08/01/1997
K964296 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA APO B TEST KIT 08/01/1997
K904125 EUCARDIO LABORATORY, INC. UC IMU A 09/24/1990
K802610 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES ALERT A,HDL-APOLIPOROTEIN A, TEST KIT 01/05/1981
K993345 KAMIYA BIOMEDICAL CO. K-ASSAY APO AI 10/25/1999
K993354 KAMIYA BIOMEDICAL CO. K-ASSAY APO B 10/28/1999
K851649 PHOTEC DIAGNOSTICS, INC. APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 06/05/1985
K854875 PHOTEC DIAGNOSTICS, INC. APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 01/24/1986
K853048 PHOTEC DIAGNOSTICS, INC. APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 08/28/1985
K910553 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE APOLIPOPROTEIN STANDARD 05/08/1991
K990594 ROCHE DIAGNOSTICS CORP. INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 04/14/1999
K013249 ROCHE DIAGNOSTICS CORP. TINA-QUANT APOLIPOPROTEIN VER.2 11/16/2001
K872078 SOLOMON PARK RESEARCH LABORATORIES QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL 06/18/1987
K840830 VENTREX LABORATORIES, INC. VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN 05/21/1984


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