FDA 510(k) Applications for Medical Device Product Code "LBS"
(Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
| 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 |
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