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 |
| 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 |
| K082488 | GENERAL ATOMICS | DIAZYME LP(A) ASSAY | 01/13/2009 |
| 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 |
| 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 |
| K211058 | Sentinel CH. SpA | Lp(a) Ultra | 12/22/2022 |
| 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 |
| 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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