Panels › Clinical Chemistry › Product code MRR · Class 1
System, Test, Low Density, Lipoprotein
Regulation 862.1475
0510(k)s in 12 months (31 all time)
1recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in MRR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2024 | K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) Siemens Healthcare Diagnostics, Inc. | MRR |
| Jul 19, 2023 | K210801 | AXINON® LDL-p Test System Numares AG, DE | MRR |
| Mar 20, 2017 | K161691 | Direct LDL Cholesterol (LDL) Randox Laboratories Limited, GB | MRR |
| Aug 3, 2009 | K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 Alfa Wassermann, Inc. | MRR |
| Jul 17, 2009 | K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES Medica Corp. | MRR |
| Jul 23, 2008 | K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS Liposcience | MRR |
| Aug 8, 2005 | K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H Teco Diagnostics | MRR |
| Jan 26, 2005 | K043264 | LDL-EX SEIKEN ASSAY KIT Denka Seiken Co., Ltd., JP | MRR |
| Nov 23, 2004 | K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 Diagnostic Chemicals , Ltd., CA | MRR |
| Aug 25, 2004 | K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc. | MRR |
| Jul 6, 2004 | K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc. | MRR |
| Sep 17, 2002 | K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT Hemagen Diagnostics, Inc. | MRR |
| May 9, 2002 | K020724 | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 Dade Behring, Inc. | MRR |
| Apr 12, 2002 | K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS Elan Diagnostics | MRR |
| Jan 28, 2002 | K014103 | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR Beckman Coulter, Inc. | MRR |
| Aug 7, 2001 | K012287 | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION Roche Diagnostics Corp. | MRR |
| Jul 3, 2000 | K993741 | EZ LDL CHOLESTEROL TEST SYSTEM Sigma Diagnostics, Inc. | MRR |
| Oct 18, 1999 | K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET Genzyme Corp. | MRR |
| Jul 13, 1999 | K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS Schiapparelli Biosystems, Inc. | MRR |
| Jan 28, 1999 | K984107 | RDI DIRECT LDL CHOLESTEROL TEST Reference Diagnostics, Inc. | MRR |
| Oct 1, 1998 | K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT Roche Diagnostic Systems, Inc. | MRR |
| Sep 22, 1998 | K982271 | WAKO DIRECT LDL-C Wako Chemicals USA, Inc. | MRR |
| Sep 11, 1998 | K982529 | RANDOX DIRECT LDL CHOLESTEROL Randox Laboratories, Ltd., GB | MRR |
| Aug 3, 1998 | K981303 | DIRECT LDL Abbott Laboratories | MRR |
| Jul 22, 1998 | K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR Pointe Scientific, Inc., | MRR |
| Nov 20, 1996 | K964064 | RDI LIPIDIRECT MAGNETIC LDL REAGENT Reference Diagnostics, Inc. | MRR |
| Nov 20, 1996 | K964063 | RDI LDL PRECIPITATION REAGENT Reference Diagnostics, Inc. | MRR |
| May 24, 1996 | K955904 | EKTACHEM DT LDL CHOLESTEROL KIT Johnson & Johnson Clinical Diagnostics, Inc. | MRR |
| Mar 15, 1995 | K943150 | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT Genzyme Corp. | MRR |
| Jan 6, 1993 | K924674 | DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT Genzyme Corp. | MRR |
| Mar 19, 1990 | K893740 | LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES Reference Diagnostics, Inc. | MRR |
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