FDA Product Code
FDA Product Code LBS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162593 | HDL-Cholesterol Gen.4 | Roche Diagnostics Operations (Rdo) | 2016-10-19 | Traditional | PDF ↗ |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | 2016-01-08 | Traditional | PDF ↗ |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | Carolina Liquid Chemistries Corp. | 2014-05-08 | Traditional | PDF ↗ |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 | Special | PDF ↗ |
| K111516 | NMR LIPOPROFILE (R) TEST AND NMR PROFILER | Liposcience, Inc. | 2011-09-27 | Traditional | PDF ↗ |
| K103747 | ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS | Elitechgroup Seppim S.A.S. | 2011-08-31 | Traditional | PDF ↗ |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT | Medica Corporation | 2011-07-12 | Traditional | PDF ↗ |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | Polymedco, Inc. | 2010-09-28 | Traditional | PDF ↗ |
| K100010 | HDL CHOLESTEROL (HDLX) ASSAY | Beckman Coulter, Inc. | 2010-05-14 | Traditional | PDF ↗ |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | Wako Chemicals USA, Inc. | 2008-07-18 | Traditional | PDF ↗ |
| K073497 | HDL CHOLESTEROL REAGENT, MODEL 10211 | Medica Corp. | 2008-04-14 | Traditional | PDF ↗ |
| K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | Diazyme Laboratories | 2008-01-03 | Traditional | PDF ↗ |
| K072836 | CHOLESTRAK HDL CHOLESTEROL HOME TEST | Accutech, LLC | 2007-12-27 | Traditional | PDF ↗ |
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Clinical Data, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K062092 | PREVU POINT OF CARE SKIN STEROL TEST | Premd, Inc. | 2006-09-15 | Special | PDF ↗ |
| K053157 | AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A | Dade Behring, Inc. | 2005-12-09 | Special | PDF ↗ |
| K051962 | ULTRA HDL | Abbott Laboratories | 2005-08-25 | Traditional | PDF ↗ |
| K050632 | ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY | Bayer Healthcare, LLC | 2005-05-26 | Traditional | PDF ↗ |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Diagnostic Chemicals , Ltd. | 2004-11-23 | Traditional | PDF ↗ |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2004-10-29 | Traditional | PDF ↗ |
| K042006 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE | Ortho-Clinical Diagnostics, Inc. | 2004-10-28 | Traditional | PDF ↗ |
| K042195 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 | Beckman Coulter, Inc. | 2004-09-16 | Traditional | PDF ↗ |
| K040767 | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT | Beckman Coulter, Inc. | 2004-06-07 | Traditional | PDF ↗ |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | Stanbio Laboratory | 2004-03-10 | Traditional | PDF ↗ |
| K033610 | HDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2003-12-05 | Special | PDF ↗ |
| K023640 | PICCOLO HDL TEST SYSTEM | Abaxis, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | Genzyme Corp. | 2002-07-25 | Traditional | PDF ↗ |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | Jas Diagnostics, Inc. | 2002-07-19 | Traditional | PDF ↗ |
| K014018 | CHOLESTEROL 1, 2, 3 | Imi | 2002-06-24 | Traditional | PDF ↗ |
| K014032 | OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | Olympus America, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K014015 | OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA | Olympus America, Inc. | 2002-02-08 | Traditional | PDF ↗ |
| K013152 | ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS | Elan Holdings, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012286 | MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2001-08-08 | Special | PDF ↗ |
| K991664 | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-19 | Traditional | PDF ↗ |
| K991665 | HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 | A.P. Total Care, Inc. | 1999-08-10 | Traditional | PDF ↗ |
| K990581 | DIRECT HDL-CHOLESTEROL REAGENT | Kamiya Biomedical Co. | 1999-06-18 | Traditional | PDF ↗ |
| K982539 | HDLC PRECIPITATING REAGENT | Ac Biochemicals, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K981224 | DIRECT HDL | Abbott Laboratories | 1998-08-03 | Traditional | PDF ↗ |
| K982341 | DIRECT HDL-CHOLESTROL LIQUID | Randox Laboratories, Ltd. | 1998-07-30 | Traditional | PDF ↗ |
| K981899 | CARESIDE HDL-CHOLESTEROL | Exigent Diagnostics, Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K981580 | HDL | Abbott Laboratories | 1998-06-11 | Traditional | PDF ↗ |
| K973988 | RDI HOMOGENEOUS HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K972041 | EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) | Sigma Diagnostics, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K971162 | LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR | Genzyme Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT | Roche Diagnostic Systems, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K971190 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K970735 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Randox Laboratories, Ltd. | 1997-06-06 | Traditional | PDF ↗ |
| K971526 | ACE HDL-C REAGENT | Schiapparelli Biosystems, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K963213 | BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL | Boehringer Mannheim Corp. | 1996-10-23 | Traditional | PDF ↗ |
| K954778 | CHOLESTECH LDX SYSTEM | Cholestech Corp. | 1995-11-24 | Traditional | PDF ↗ |
| K943279 | ACCUMETER HDL CHOLESTEROL TEST | Chemtrak, Inc. | 1995-05-01 | Traditional | PDF ↗ |
| K943028 | HDL QVET | Prisma Systems | 1994-12-07 | Traditional | PDF ↗ |
| K934045 | BECKMAN HDL CHOLESTEROL REAGENT | Beckman Instruments, Inc. | 1993-10-14 | Traditional | PDF ↗ |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | Technicon Instruments Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K905296 | CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL | Cholestech Corp. | 1990-12-26 | Traditional | PDF ↗ |
| K900036 | IMMUNOTECH HDL-CHOLESTEROL TEST | Immunotech Corp. | 1990-03-09 | Traditional | PDF ↗ |
| K895139 | CLINISTAT HDL CHOLESTEROL REAGENT TEST | Heraeus Kulzer, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K895851 | SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT | Beckman Instruments, Inc. | 1989-11-29 | Traditional | PDF ↗ |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Photec Diagnostics, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K893548 | SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP | Heraeus Kulzer, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K881891 | IQ HDL CHOLESTEROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-10 | Traditional | PDF ↗ |
| K874397 | EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 | Em Diagnostic Systems, Inc. | 1987-11-24 | Traditional | PDF ↗ |
| K871265 | ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL | E.I. Dupont DE Nemours & Co., Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K872050 | PARAMAX CHOLESTEROL REAGENT | American Dade | 1987-07-07 | Traditional | PDF ↗ |
| K871461 | VISION (TM) HDL CHOLESTEROL | Abbott Laboratories | 1987-05-14 | Traditional | PDF ↗ |
| K864522 | ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE | Beckman Instruments, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K861244 | HDL/CHOLESTEROL TEST SYSTEM | Chrometrics Laboratories, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862845 | EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 | Em Diagnostic Systems, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K843029 | HIGH DENSITY LIPOPROTEIN PRECIPITATIN | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-27 | Traditional | PDF ↗ |
| K840677 | HDL EZ-TZ3 CHOLESTEROL REAGENT KIT | Preventive Diagnostics Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K840676 | PDC HDL EZ-SEP CHOLESTEROL REAGENT | Preventive Diagnostics Corp. | 1984-04-04 | Traditional | PDF ↗ |
| K813192 | HDL-C EIKEN | Syn-Kit, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K801834 | WAKO HDL CHOLESTEROL TEST | Wako Pure Chemical Industries, Ltd. | 1980-09-16 | Traditional | PDF ↗ |
| K801726 | HDL CHOLESTEROL TEST KIT | Mallinckrodt Critical Care | 1980-09-09 | Traditional | PDF ↗ |
| K801133 | CENTRIFICHEM HDL CHOLESTEROL | Union Carbide Corp. | 1980-06-17 | Traditional | PDF ↗ |
| K792319 | COULTER HDL CHOLESTEROL REAG. SYSTEM | Coulter Electronics, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | Dade, Baxter Travenol Diagnostics, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791990 | TECHNICON HDL CHOLESTEROL METHOD | Technicon Instruments Corp. | 1979-10-17 | Traditional | PDF ↗ |
| K790553 | CHOLESTEROL KIT, HDL-DS | Beckman Instruments, Inc. | 1979-06-15 | Traditional | PDF ↗ |
| K790281 | DIAGNOSTIC SET, LIPO-FRAX | Analytical Products, Inc. | 1979-03-21 | Traditional | PDF ↗ |
Product code LBS · Class I · Clinical Chemistry. Data: openFDA.