FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K981303 |
ABBOTT LABORATORIES |
DIRECT LDL |
08/03/1998 |
K091333 |
ALFA WASSERMANN, INC. |
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 |
08/03/2009 |
K014103 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
01/28/2002 |
K020724 |
DADE BEHRING, INC. |
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 |
05/09/2002 |
K043264 |
DENKA SEIKEN CO., LTD. |
LDL-EX SEIKEN ASSAY KIT |
01/26/2005 |
K041927 |
DIAGNOSTIC CHEMICALS LTD. |
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 |
11/23/2004 |
K020575 |
ELAN DIAGNOSTICS |
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS |
04/12/2002 |
K992766 |
GENZYME CORP. |
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET |
10/18/1999 |
K022772 |
HEMAGEN DIAGNOSTICS, INC. |
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT |
09/17/2002 |
K955904 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
EKTACHEM DT LDL CHOLESTEROL KIT |
05/24/1996 |
K063841 |
LIPOSCIENCE |
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
07/23/2008 |
K090734 |
MEDICA CORP. |
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES |
07/17/2009 |
K210801 |
numares AG |
AXINON« LDL-p Test System |
07/19/2023 |
K041720 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II |
08/25/2004 |
K981978 |
POINTE SCIENTIFIC, INC. |
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR |
07/22/1998 |
K040693 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
PTS PANELS LDL CHOLESTEROL TEST STRIPS |
07/06/2004 |
K161691 |
RANDOX LABORATORIES LIMITED |
Direct LDL Cholesterol (LDL) |
03/20/2017 |
K982529 |
RANDOX LABORATORIES, LTD. |
RANDOX DIRECT LDL CHOLESTEROL |
09/11/1998 |
K984107 |
REFERENCE DIAGNOSTICS, INC. |
RDI DIRECT LDL CHOLESTEROL TEST |
01/28/1999 |
K964063 |
REFERENCE DIAGNOSTICS, INC. |
RDI LDL PRECIPITATION REAGENT |
11/20/1996 |
K964064 |
REFERENCE DIAGNOSTICS, INC. |
RDI LIPIDIRECT MAGNETIC LDL REAGENT |
11/20/1996 |
K982848 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT |
10/01/1998 |
K012287 |
ROCHE DIAGNOSTICS CORP. |
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION |
08/07/2001 |
K991733 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS |
07/13/1999 |
K993741 |
SIGMA DIAGNOSTICS, INC. |
EZ LDL CHOLESTEROL TEST SYSTEM |
07/03/2000 |
K051121 |
TECO DIAGNOSTICS |
DIRECT LDL CHOLESTEROL, MODEL L530-60H |
08/08/2005 |
K982271 |
WAKO CHEMICALS, USA, INC. |
WAKO DIRECT LDL-C |
09/22/1998 |