LBR · Ldl & Vldl Precipitation, Hdl
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | LBR |
|---|---|
| Device Name | Ldl & Vldl Precipitation, Hdl |
| 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 66)
Showing 20 most recent of 66 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | Roche Diagnostics Operations (Rdo) | Jan 28, 2015 | SESE |
| K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | General Atomics | Jan 22, 2008 | SESE |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | Teco Diagnostics | Jul 26, 2005 | SESE |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | Hemagen Diagnostics, Inc. | Dec 24, 2002 | SESE |
| K012593 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | Aug 30, 2001 | SESE |
| K992029 | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Diagnostics | Aug 12, 1999 | SESE |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | Pointe Scientific, Inc., | Aug 5, 1999 | SESE |
| K991789 | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | Elan Holdings, Inc. | Jul 9, 1999 | SESE |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | May 28, 1999 | SESE |
| K984303 | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT | Ortho-Clinical Diagnostics, Inc. | Jan 28, 1999 | SESE |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | Diagnostic Chemicals , Ltd. | Apr 27, 1998 | SESE |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | Diagnostic Chemicals , Ltd. | Apr 21, 1998 | SESE |
| K974733 | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | Boehringer Mannheim Corp. | Jan 26, 1998 | SESE |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | Roche Diagnostic Systems, Inc. | Nov 21, 1997 | SESE |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | Genzyme Corp. | Jun 18, 1997 | SESE |
| K962723 | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | Trace America, Inc. | Mar 13, 1997 | SESE |
| K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | Genzyme Corp. | Aug 19, 1996 | SESE |
| K954179 | HDL PRECIPITATING REAGENT | Schiapparelli Biosystems, Inc. | Dec 11, 1995 | SESE |
| K944975 | MAGNETIC HDL CHOLESTEROL TEST | Reference Diagnostics, Inc. | Aug 2, 1995 | SESE |
| K941744 | PBI PLUS HDL PRECIPITATING REAGENT | Merchant House Scientific | Sep 6, 1994 | SESE |
Top Applicants
- Genzyme Corp. — 3 clearances
- Merchant House Scientific — 3 clearances
- Pointe Scientific, Inc., — 3 clearances
- American Monitor Corp. — 2 clearances
- Boehringer Mannheim Corp. — 2 clearances
