FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K991665 |
A.P. TOTAL CARE, INC. |
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 |
08/10/1999 |
K991664 |
A.P. TOTAL CARE, INC. |
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 |
08/19/1999 |
K023640 |
ABAXIS, INC. |
PICCOLO HDL TEST SYSTEM |
01/24/2003 |
K981224 |
ABBOTT LABORATORIES |
DIRECT HDL |
08/03/1998 |
K981580 |
ABBOTT LABORATORIES |
HDL |
06/11/1998 |
K051962 |
ABBOTT LABORATORIES |
ULTRA HDL |
08/25/2005 |
K982539 |
AC BIOCHEMICALS, INC. |
HDLC PRECIPITATING REAGENT |
09/15/1998 |
K072836 |
ACCUTECH, LLC. |
CHOLESTRAK HDL CHOLESTEROL HOME TEST |
12/27/2007 |
K050632 |
BAYER HEALTHCARE, LLC |
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY |
05/26/2005 |
K100010 |
BECKMAN COULTER, INC. |
HDL CHOLESTEROL (HDLX) ASSAY |
05/14/2010 |
K042195 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 |
09/16/2004 |
K040767 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT |
06/07/2004 |
K963213 |
BOEHRINGER MANNHEIM CORP. |
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL |
10/23/1996 |
K132711 |
CAROLINA LIQUID CHEMISTRIES CORP. |
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT |
05/08/2014 |
K071706 |
CLINICAL DATA, INC. |
ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) |
12/20/2007 |
K053157 |
DADE BEHRING, INC. |
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A |
12/09/2005 |
K041090 |
DENKA SEIKEN CO., LTD. |
HDL-EX SEIKEN ASSAY KIT |
10/29/2004 |
K041928 |
DIAGNOSTIC CHEMICALS LTD. |
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B |
11/23/2004 |
K072395 |
DIAZYME LABORATORIES |
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS |
01/03/2008 |
K013152 |
ELAN HOLDINGS, INC. |
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS |
11/09/2001 |
K103747 |
ELITECHGROUP SEPPIM S.A.S. |
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS |
08/31/2011 |
K981899 |
EXIGENT DIAGNOSTICS, INC. |
CARESIDE HDL-CHOLESTEROL |
07/14/1998 |
K971162 |
GENZYME CORP. |
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR |
06/16/1997 |
K971190 |
GENZYME CORP. |
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR |
06/16/1997 |
K021316 |
GENZYME CORP. |
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR |
07/25/2002 |
K014018 |
IMI |
CHOLESTEROL 1, 2, 3 |
06/24/2002 |
K021671 |
JAS Diagnostics, Inc. |
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT |
07/19/2002 |
K990581 |
KAMIYA BIOMEDICAL CO. |
DIRECT HDL-CHOLESTEROL REAGENT |
06/18/1999 |
K111516 |
LIPOSCIENCE, INC |
NMR LIPOPROFILE (R) TEST AND NMR PROFILER |
09/27/2011 |
K073497 |
MEDICA CORP. |
HDL CHOLESTEROL REAGENT, MODEL 10211 |
04/14/2008 |
K111036 |
MEDICA CORPORATION |
EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT |
07/12/2011 |
K014015 |
OLYMPUS AMERICA, INC. |
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
02/08/2002 |
K014032 |
OLYMPUS AMERICA, INC. |
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA |
02/08/2002 |
K120609 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS DHDL SLIDES |
09/07/2012 |
K042006 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE |
10/28/2004 |
K100550 |
POLYMEDCO, INC. |
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC |
09/28/2010 |
K062092 |
PREMD, INC. |
PREVU POINT OF CARE SKIN STEROL TEST |
09/15/2006 |
K153435 |
Randox Laboratories Ltd |
Direct HDL Cholesterol (HDL) |
01/08/2016 |
K970735 |
RANDOX LABORATORIES, LTD. |
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL |
06/06/1997 |
K982341 |
RANDOX LABORATORIES, LTD. |
DIRECT HDL-CHOLESTROL LIQUID |
07/30/1998 |
K973988 |
REFERENCE DIAGNOSTICS, INC. |
RDI HOMOGENEOUS HDL CHOLESTEROL TEST |
12/22/1997 |
K971902 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT |
06/16/1997 |
K033610 |
ROCHE DIAGNOSTICS CORP. |
HDL-CHOLESTEROL PLUS 2ND GENERATION |
12/05/2003 |
K012286 |
ROCHE DIAGNOSTICS CORP. |
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION |
08/08/2001 |
K162593 |
Roche Diagnostics Operations (RDO) |
HDL-Cholesterol Gen.4 |
10/19/2016 |
K971526 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE HDL-C REAGENT |
05/21/1997 |
K972041 |
SIGMA DIAGNOSTICS, INC. |
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) |
07/22/1997 |
K032932 |
STANBIO LABORATORY |
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR |
03/10/2004 |
K080125 |
WAKO CHEMICALS USA, INC. |
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 |
07/18/2008 |