| HDL-Cholesterol Gen.4 (K162593) | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| Direct HDL Cholesterol (HDL) (K153435) | Randox Laboratories, Ltd. | 2016-01-08 |
| CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711) | Carolina Liquid Chemistries Corp. | 2014-05-08 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609) | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516) | Liposcience, Inc. | 2011-09-27 |
| ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747) | Elitechgroup Seppim S.A.S. | 2011-08-31 |
| EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036) | Medica Corporation | 2011-07-12 |
| POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550) | Polymedco, Inc. | 2010-09-28 |
| HDL CHOLESTEROL (HDLX) ASSAY (K100010) | Beckman Coulter, Inc. | 2010-05-14 |
| APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125) | Wako Chemicals USA, Inc. | 2008-07-18 |
| HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497) | Medica Corp. | 2008-04-14 |
| DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395) | Diazyme Laboratories | 2008-01-03 |
| CHOLESTRAK HDL CHOLESTEROL HOME TEST (K072836) | Accutech, LLC | 2007-12-27 |
| ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) (K071706) | Clinical Data, Inc. | 2007-12-20 |
| PREVU POINT OF CARE SKIN STEROL TEST (K062092) | Premd, Inc. | 2006-09-15 |
| AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A (K053157) | Dade Behring, Inc. | 2005-12-09 |
| ULTRA HDL (K051962) | Abbott Laboratories | 2005-08-25 |
| ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY (K050632) | Bayer Healthcare, LLC | 2005-05-26 |
| HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (K041928) | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| HDL-EX SEIKEN ASSAY KIT (K041090) | Denka Seiken Co., Ltd. | 2004-10-29 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE (K042006) | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 (K042195) | Beckman Coulter, Inc. | 2004-09-16 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT (K040767) | Beckman Coulter, Inc. | 2004-06-07 |
| DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (K032932) | Stanbio Laboratory | 2004-03-10 |
| HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610) | Roche Diagnostics Corp. | 2003-12-05 |
| PICCOLO HDL TEST SYSTEM (K023640) | Abaxis, Inc. | 2003-01-24 |
| ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316) | Genzyme Corp. | 2002-07-25 |
| JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (K021671) | Jas Diagnostics, Inc. | 2002-07-19 |
| CHOLESTEROL 1, 2, 3 (K014018) | Imi | 2002-06-24 |
| OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014032) | Olympus America, Inc. | 2002-02-08 |
| OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014015) | Olympus America, Inc. | 2002-02-08 |
| ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (K013152) | Elan Holdings, Inc. | 2001-11-09 |
| MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION (K012286) | Roche Diagnostics Corp. | 2001-08-08 |
| LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (K991664) | A.P. Total Care, Inc. | 1999-08-19 |
| HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (K991665) | A.P. Total Care, Inc. | 1999-08-10 |
| DIRECT HDL-CHOLESTEROL REAGENT (K990581) | Kamiya Biomedical Co. | 1999-06-18 |
| HDLC PRECIPITATING REAGENT (K982539) | Ac Biochemicals, Inc. | 1998-09-15 |
| DIRECT HDL (K981224) | Abbott Laboratories | 1998-08-03 |
| DIRECT HDL-CHOLESTROL LIQUID (K982341) | Randox Laboratories, Ltd. | 1998-07-30 |
| CARESIDE HDL-CHOLESTEROL (K981899) | Exigent Diagnostics, Inc. | 1998-07-14 |
| HDL (K981580) | Abbott Laboratories | 1998-06-11 |
| RDI HOMOGENEOUS HDL CHOLESTEROL TEST (K973988) | Reference Diagnostics, Inc. | 1997-12-22 |
| EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) (K972041) | Sigma Diagnostics, Inc. | 1997-07-22 |
| LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR (K971162) | Genzyme Corp. | 1997-06-16 |
| N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K971190) | Genzyme Corp. | 1997-06-16 |
| ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902) | Roche Diagnostic Systems, Inc. | 1997-06-16 |
| BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K970735) | Randox Laboratories, Ltd. | 1997-06-06 |
| ACE HDL-C REAGENT (K971526) | Schiapparelli Biosystems, Inc. | 1997-05-21 |
| BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K963213) | Boehringer Mannheim Corp. | 1996-10-23 |
| CHOLESTECH LDX SYSTEM (K954778) | Cholestech Corp. | 1995-11-24 |
| ACCUMETER HDL CHOLESTEROL TEST (K943279) | Chemtrak, Inc. | 1995-05-01 |
| HDL QVET (K943028) | Prisma Systems | 1994-12-07 |
| BECKMAN HDL CHOLESTEROL REAGENT (K934045) | Beckman Instruments, Inc. | 1993-10-14 |
| TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (K914511) | Technicon Instruments Corp. | 1991-11-27 |
| CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL (K905296) | Cholestech Corp. | 1990-12-26 |
| IMMUNOTECH HDL-CHOLESTEROL TEST (K900036) | Immunotech Corp. | 1990-03-09 |
| CLINISTAT HDL CHOLESTEROL REAGENT TEST (K895139) | Heraeus Kulzer, Inc. | 1989-12-27 |
| SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT (K895851) | Beckman Instruments, Inc. | 1989-11-29 |
| QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (K894057) | Photec Diagnostics, Inc. | 1989-08-31 |
| SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP (K893548) | Heraeus Kulzer, Inc. | 1989-08-03 |
| IQ HDL CHOLESTEROL (K881891) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-10 |
| EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 (K874397) | Em Diagnostic Systems, Inc. | 1987-11-24 |
| ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL (K871265) | E.I. Dupont DE Nemours & Co., Inc. | 1987-08-13 |
| PARAMAX CHOLESTEROL REAGENT (K872050) | American Dade | 1987-07-07 |
| VISION (TM) HDL CHOLESTEROL (K871461) | Abbott Laboratories | 1987-05-14 |
| ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE (K864522) | Beckman Instruments, Inc. | 1987-02-04 |
| HDL/CHOLESTEROL TEST SYSTEM (K861244) | Chrometrics Laboratories, Inc. | 1986-09-29 |
| EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 (K862845) | Em Diagnostic Systems, Inc. | 1986-08-29 |
| HIGH DENSITY LIPOPROTEIN PRECIPITATIN (K843029) | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-27 |
| HDL EZ-TZ3 CHOLESTEROL REAGENT KIT (K840677) | Preventive Diagnostics Corp. | 1984-04-13 |
| PDC HDL EZ-SEP CHOLESTEROL REAGENT (K840676) | Preventive Diagnostics Corp. | 1984-04-04 |
| HDL-C EIKEN (K813192) | Syn-Kit, Inc. | 1981-11-27 |
| WAKO HDL CHOLESTEROL TEST (K801834) | Wako Pure Chemical Industries, Ltd. | 1980-09-16 |
| HDL CHOLESTEROL TEST KIT (K801726) | Mallinckrodt Critical Care | 1980-09-09 |
| CENTRIFICHEM HDL CHOLESTEROL (K801133) | Union Carbide Corp. | 1980-06-17 |
| COULTER HDL CHOLESTEROL REAG. SYSTEM (K792319) | Coulter Electronics, Inc. | 1979-12-06 |
| DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (K792183) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-13 |
| TECHNICON HDL CHOLESTEROL METHOD (K791990) | Technicon Instruments Corp. | 1979-10-17 |
| CHOLESTEROL KIT, HDL-DS (K790553) | Beckman Instruments, Inc. | 1979-06-15 |
| DIAGNOSTIC SET, LIPO-FRAX (K790281) | Analytical Products, Inc. | 1979-03-21 |