FDA Product Code
FDA Product Code LBR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 66 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | 2015-01-28 | Traditional | PDF ↗ |
| K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | General Atomics | 2008-01-22 | Traditional | PDF ↗ |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | Teco Diagnostics | 2005-07-26 | Traditional | PDF ↗ |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | Hemagen Diagnostics, Inc. | 2002-12-24 | Special | PDF ↗ |
| K012593 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 | Special | PDF ↗ |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Diagnostics | 1999-08-12 | Traditional | PDF ↗ |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | Pointe Scientific, Inc., | 1999-08-05 | Traditional | PDF ↗ |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Holdings, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999-05-28 | Traditional | PDF ↗ |
| K984303 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT | Ortho-Clinical Diagnostics, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | Diagnostic Chemicals , Ltd. | 1998-04-27 | Traditional | PDF ↗ |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | Diagnostic Chemicals , Ltd. | 1998-04-21 | Traditional | PDF ↗ |
| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | 1998-01-26 | Traditional | PDF ↗ |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1997-06-18 | Traditional | PDF ↗ |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Trace America, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | 1996-08-19 | Traditional | PDF ↗ |
| K954179 | HDL PRECIPITATING REAGENT | Schiapparelli Biosystems, Inc. | 1995-12-11 | Traditional | PDF ↗ |
| K944975 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1995-08-02 | Traditional | PDF ↗ |
| K941744 | PBI PLUS HDL PRECIPITATING REAGENT | Merchant House Scientific | 1994-09-06 | Traditional | PDF ↗ |
| K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) | Diagnostic Chemicals, Ltd. (Usa) | 1993-12-10 | Traditional | PDF ↗ |
| K934961 | SPINPRO HDL PRECIPITATING REAGENT | Merchant House Scientific | 1993-12-09 | Traditional | PDF ↗ |
| K934801 | SPINPRO HDL PRECIPITATING REAGENT | Merchant House Scientific | 1993-12-07 | Traditional | PDF ↗ |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | Intersect Systems, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | King Diagnostics, Inc. | 1993-08-16 | Traditional | PDF ↗ |
| K924427 | SYNERMED HDL CHOLESTLEROL REAGENT KIT | Synermed, Inc. | 1992-11-09 | Traditional | PDF ↗ |
| K914811 | IL TEST(TM) HDL CHOLESTEROL | Instrumentation Laboratory CO | 1992-01-09 | Traditional | PDF ↗ |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | Creative Laboratory Products, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K911906 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1991-07-18 | Traditional | PDF ↗ |
| K911406 | HDL CHOLESTEROL REAGENT | Genzyme Corp. | 1991-05-22 | Traditional | PDF ↗ |
| K903733 | ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM | Institute For Clinical Applications | 1991-01-15 | Traditional | PDF ↗ |
| K905284 | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 | Amresco, Inc. | 1990-12-11 | Traditional | PDF ↗ |
| K904184 | BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT | Biotron U.S.A., Inc. | 1990-11-28 | Traditional | PDF ↗ |
| K903094 | STAT TEST HDL/CHOLESTEROL TEST KIT | Diagnostic Resources, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K902568 | REFLOTRON HDL CHOLESTEROL TEST TABS | Boehringer Mannheim Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K902174 | COULTER HDL - CHOLESTEROL REAGENT | Coulter Corp. | 1990-07-31 | Traditional | PDF ↗ |
| K900120 | ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL | Roche Diagnostic Systems, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K895381 | HDL SINGLES | Trace America, Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K893966 | HDL PRECIPITATING REAGENT | Diagnostic Systems | 1989-07-25 | Traditional | PDF ↗ |
| K891117 | HDL CHOLESTEROL REAGENT | Pointe Scientific, Inc., | 1989-04-10 | Traditional | PDF ↗ |
| K890669 | STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE | Norfolk Scientific, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K890023 | HDL CHOLESTEROL REAGENT (PTA/MGCL2) | Sigma Diagnostics, Inc. | 1989-02-17 | Traditional | PDF ↗ |
| K885265 | HDL CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K883353 | IQ HDL CHOLESTEROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-13 | Traditional | PDF ↗ |
| K882488 | CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES | Canyon Diagnostics, Inc. | 1988-08-15 | Traditional | PDF ↗ |
| K881244 | HDL CHOLESTEROL KIT | Trace Scientific , Ltd. | 1988-06-10 | Traditional | PDF ↗ |
| K881326 | HDL CHOLESTEROL PRECIPITATING PROCEDURE | Data Medical Associates, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K880176 | HDL CHOLESTEROL PRECIPITATING REAGENT | Tech-Co, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Simmler, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K861926 | WORTHINGTON HDL PRECIPITATING REAGENT SET | Cooper Biomedical, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K852350 | HDL CHOLESTEROL PRETREATMENT | American Monitor Corp. | 1985-07-08 | Traditional | PDF ↗ |
| K843894 | HDL PRECIPATATING REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-02 | Traditional | PDF ↗ |
| K834251 | HDL CHOLESTEROL PRETREATMENT | American Monitor Corp. | 1984-02-13 | Traditional | PDF ↗ |
| K833160 | HDL EZ-TAB | Preventive Diagnostics Corp. | 1984-02-09 | Traditional | PDF ↗ |
| K833431 | HDL EX-SEP PRECIPITATING REAGENT | Preventive Diagnostics Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K830207 | RAICHEM HDL-CHOLESTEROL REAGENT | Reagents Applications, Inc. | 1983-03-21 | Traditional | PDF ↗ |
| K821203 | HDL PRECIPITANT REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K812839 | HDL CHOLESTEROL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | Traditional | PDF ↗ |
| K812574 | HDL CHOLESTEROL REAGENT | Pointe Scientific, Inc., | 1981-09-24 | Traditional | PDF ↗ |
| K800996 | HDL REAGENT | Gilford Diagnostics | 1980-05-14 | Traditional | PDF ↗ |
| K792313 | CHOL-HDL TEST, HIGH LIPO. CHOL TEST | Sclavo, Inc. | 1979-12-07 | Traditional | PDF ↗ |
| K790865 | LANCER HDL SEPARATION KIT | Sherwood Medical Co. | 1979-06-28 | Traditional | PDF ↗ |
| K790372 | H-D-EL | General Diagnostics | 1979-05-03 | Traditional | PDF ↗ |
| K790329 | A-GENT-HDL REAGENT | Abbott Laboratories | 1979-04-04 | Traditional | PDF ↗ |
| K781093 | HDL CENTRIFIKIT | Beckman Instruments, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K780542 | ALFATEST | Panmed, Inc. | 1978-05-19 | Traditional | PDF ↗ |
Product code LBR · Class I · Clinical Chemistry. Data: openFDA.