FDA Product Code
FDA Product Code MRR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 | Traditional | PDF ↗ |
| K210801 | AXINON® LDL-p Test System | Numares AG | 2023-07-19 | Traditional | PDF ↗ |
| K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | 2017-03-20 | Traditional | PDF ↗ |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Alfa Wassermann, Inc. | 2009-08-03 | Traditional | PDF ↗ |
| K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | Medica Corp. | 2009-07-17 | Traditional | PDF ↗ |
| K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | Liposcience | 2008-07-23 | Traditional | PDF ↗ |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | Teco Diagnostics | 2005-08-08 | Traditional | PDF ↗ |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2005-01-26 | Traditional | PDF ↗ |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | Diagnostic Chemicals , Ltd. | 2004-11-23 | Traditional | PDF ↗ |
| K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 | Traditional | PDF ↗ |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | 2004-07-06 | Traditional | PDF ↗ |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Hemagen Diagnostics, Inc. | 2002-09-17 | Traditional | PDF ↗ |
| K020724 | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 | Dade Behring, Inc. | 2002-05-09 | Traditional | PDF ↗ |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | Elan Diagnostics | 2002-04-12 | Traditional | PDF ↗ |
| K014103 | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K012287 | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2001-08-07 | Special | PDF ↗ |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | Sigma Diagnostics, Inc. | 2000-07-03 | Traditional | PDF ↗ |
| K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | 1999-10-18 | Traditional | PDF ↗ |
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Schiapparelli Biosystems, Inc. | 1999-07-13 | Traditional | PDF ↗ |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | Roche Diagnostic Systems, Inc. | 1998-10-01 | Traditional | PDF ↗ |
| K982271 | WAKO DIRECT LDL-C | Wako Chemicals USA, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982529 | RANDOX DIRECT LDL CHOLESTEROL | Randox Laboratories, Ltd. | 1998-09-11 | Traditional | PDF ↗ |
| K981303 | DIRECT LDL | Abbott Laboratories | 1998-08-03 | Traditional | PDF ↗ |
| K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | Pointe Scientific, Inc., | 1998-07-22 | Traditional | PDF ↗ |
| K964064 | RDI LIPIDIRECT MAGNETIC LDL REAGENT | Reference Diagnostics, Inc. | 1996-11-20 | Traditional | PDF ↗ |
| K964063 | RDI LDL PRECIPITATION REAGENT | Reference Diagnostics, Inc. | 1996-11-20 | Traditional | PDF ↗ |
| K955904 | EKTACHEM DT LDL CHOLESTEROL KIT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-24 | Traditional | PDF ↗ |
| K943150 | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT | Genzyme Corp. | 1995-03-15 | Traditional | PDF ↗ |
| K924674 | DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT | Genzyme Corp. | 1993-01-06 | Traditional | PDF ↗ |
| K893740 | LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES | Reference Diagnostics, Inc. | 1990-03-19 | Traditional | PDF ↗ |
Product code MRR · Class I · Clinical Chemistry. Data: openFDA.