FDA 510(k) Applications for Medical Device Product Code "DFC"
(Lipoprotein, Low-Density, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983281 ABBOTT LABORATORIES APOB 01/26/1999
K980812 AXIS BIOCHEMICALS, ASA IMX HOMOCYSTEINE 10/01/1998
K000121 BECKMAN COULTER, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB 05/17/2000
K903122 BINAX, INC. EQUATE(TM) AQR APO AL/B DUO CONTROL 08/02/1990
K050487 BIOKIT S.A. QUANTIA LA(A) 04/26/2005
K013128 DADE BEHRING, INC. N LATEX LP(A) 01/18/2002
K013359 DENKA SEIKEN'S LP(A)-LATEX SEIKEN ASSAY KIT 03/08/2002
K993669 DIASORIN, INC. LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET 11/17/1999
K001118 DIASORIN, INC. MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET 04/25/2000
K982708 DIASORIN, INC. SPQ TEST SYSTEM 04/02/1999
K994110 DIASORIN/AMERICAN STANDARD COMPANIES LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET 12/21/1999
K180074 Diazyme Laboratories, Inc. Diazyme Lipoprotein (a) Assay 03/22/2018
K904137 EUCARDIO LABORATORY, INC. UC IMU B 11/21/1990
K771812 GELMAN INSTRUMENT CO. LIPPOPROTEIN ELECTROPHORESIS REAGENT SET 10/18/1977
K082488 GENERAL ATOMICS DIAZYME LP(A) ASSAY 01/13/2009
K771912 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R BETA LIPOPROTEIN TEST 10/19/1977
K781015 ICL SCIENTIFIC ANTI-HUMAN LDL SERUM 08/14/1978
K923079 INSTRUMENTATION LABORATORY CO. IL TEST CALIBRATION SET APO A1B 02/05/1993
K883711 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CALIBRATOR F PACK 09/22/1988
K883712 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CONTROL F PACK 09/22/1988
K021660 KAMIYA BIOMEDICAL CO. K-ASSAY LP(A) ASSAY 07/25/2002
K023853 KAMIYA BIOMEDICAL CO. K-ASSAY LP(A) CONTROLS 12/13/2002
K970302 PERIMMUNE, INC. APO-TEK LP(A) 11/10/1997
K872080 REAGENTS APPLICATIONS, INC. RAICHEM(TM) SPIA(TM) APO B REAGENTS 06/15/1987
K122722 Roche Diagnostics COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 11/29/2012
K990595 ROCHE DIAGNOSTICS CORP. INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B 04/14/1999
K013206 ROCHE DIAGNOSTICS CORP. TINA-QUANT APOLIPOPROTEIN B VER.2 11/16/2001
K013207 ROCHE DIAGNOSTICS CORP. TINA-QUANT APOLIPOPROTEIN B VER.2 11/13/2001
K123046 Siemens Healthcare Diagnostics Inc. ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR 12/20/2012
K063838 THERMO ELECTRON OY LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH 09/27/2007
K992665 TRINITY BIOTECH USA MACRA LP(A) ENZYME IMMUNOASSAY KIT 11/26/1999
K954657 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT APO B 12/20/1995
K981446 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A) 03/09/1999
K001931 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET 07/24/2000
K001934 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX 07/24/2000
K001933 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO 07/24/2000
K001929 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA 07/24/2000
K001920 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A)/ RA,500/1000, 07/23/2000
K001919 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A)/DADE DEMENSION 07/23/2000
K001921 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LP(A)/EXPRESS 550 07/23/2000


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