FDA 510(k) Applications for Medical Device Product Code "MRR"
(System, Test, Low Density, Lipoprotein)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981303 | ABBOTT LABORATORIES | DIRECT LDL | 08/03/1998 |
| K091333 | ALFA WASSERMANN, INC. | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | 08/03/2009 |
| K014103 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR | 01/28/2002 |
| K020724 | DADE BEHRING, INC. | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 | 05/09/2002 |
| K043264 | DENKA SEIKEN CO., LTD. | LDL-EX SEIKEN ASSAY KIT | 01/26/2005 |
| K041927 | DIAGNOSTIC CHEMICALS LTD. | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | 11/23/2004 |
| K020575 | ELAN DIAGNOSTICS | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | 04/12/2002 |
| K992766 | GENZYME CORP. | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | 10/18/1999 |
| K022772 | HEMAGEN DIAGNOSTICS, INC. | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | 09/17/2002 |
| K955904 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | EKTACHEM DT LDL CHOLESTEROL KIT | 05/24/1996 |
| K063841 | LIPOSCIENCE | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | 07/23/2008 |
| K090734 | MEDICA CORP. | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | 07/17/2009 |
| K210801 | numares AG | AXINON« LDL-p Test System | 07/19/2023 |
| K041720 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II | 08/25/2004 |
| K981978 | POINTE SCIENTIFIC, INC. | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | 07/22/1998 |
| K040693 | POLYMER TECHNOLOGY SYSTEMS, INC. | PTS PANELS LDL CHOLESTEROL TEST STRIPS | 07/06/2004 |
| K161691 | RANDOX LABORATORIES LIMITED | Direct LDL Cholesterol (LDL) | 03/20/2017 |
| K982529 | RANDOX LABORATORIES, LTD. | RANDOX DIRECT LDL CHOLESTEROL | 09/11/1998 |
| K984107 | REFERENCE DIAGNOSTICS, INC. | RDI DIRECT LDL CHOLESTEROL TEST | 01/28/1999 |
| K964063 | REFERENCE DIAGNOSTICS, INC. | RDI LDL PRECIPITATION REAGENT | 11/20/1996 |
| K964064 | REFERENCE DIAGNOSTICS, INC. | RDI LIPIDIRECT MAGNETIC LDL REAGENT | 11/20/1996 |
| K982848 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | 10/01/1998 |
| K012287 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION | 08/07/2001 |
| K991733 | SCHIAPPARELLI BIOSYSTEMS, INC. | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | 07/13/1999 |
| K993741 | SIGMA DIAGNOSTICS, INC. | EZ LDL CHOLESTEROL TEST SYSTEM | 07/03/2000 |
| K051121 | TECO DIAGNOSTICS | DIRECT LDL CHOLESTEROL, MODEL L530-60H | 08/08/2005 |
| K982271 | WAKO CHEMICALS, USA, INC. | WAKO DIRECT LDL-C | 09/22/1998 |
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