MRR · System, Test, Low Density, Lipoprotein
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | MRR |
|---|---|
| Device Name | System, Test, Low Density, Lipoprotein |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | Jul 26, 2024 | SESE |
| K210801 | AXINON® LDL-p Test System | Numares AG | Jul 19, 2023 | SESE |
| K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | Mar 20, 2017 | SESE |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Alfa Wassermann, Inc. | Aug 3, 2009 | SESE |
| K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | Medica Corp. | Jul 17, 2009 | SESE |
| K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | Liposcience | Jul 23, 2008 | SESE |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | Teco Diagnostics | Aug 8, 2005 | SESE |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | Jan 26, 2005 | SESE |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | Diagnostic Chemicals , Ltd. | Nov 23, 2004 | SESE |
| K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | Aug 25, 2004 | SESE |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | Jul 6, 2004 | SESE |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Hemagen Diagnostics, Inc. | Sep 17, 2002 | SESE |
| K020724 | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 | Dade Behring, Inc. | May 9, 2002 | SESE |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | Elan Diagnostics | Apr 12, 2002 | SESE |
| K014103 | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | Jan 28, 2002 | SESE |
| K012287 | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | Aug 7, 2001 | SESE |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | Sigma Diagnostics, Inc. | Jul 3, 2000 | SESE |
| K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | Oct 18, 1999 | SESE |
| K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | Schiapparelli Biosystems, Inc. | Jul 13, 1999 | SESE |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | Jan 28, 1999 | SESE |
Top Applicants
- Reference Diagnostics, Inc. — 4 clearances
- Genzyme Corp. — 3 clearances
- Abbott Laboratories — 1 clearance
- Alfa Wassermann, Inc. — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
