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