LBR — Ldl & Vldl Precipitation, Hdl Class I
FDA product code LBR covers "Ldl & Vldl Precipitation, Hdl", a Class I medical device regulated under 21 CFR 862.1475. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBR
- Device Class
- Class I
- Regulation Number
- 862.1475
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143691 | roche diagnostics operations (rdo) | LDLC3 LDL-Cholesterol Gen.3 | January 28, 2015 |
| K072523 | general atomics | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | January 22, 2008 |
| K050823 | teco diagnostics | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | July 26, 2005 |
| K023784 | hemagen diagnostics | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA | December 24, 2002 |
| K012593 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO | August 30, 2001 |
| K992029 | elan diagnostics | ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | August 12, 1999 |
| K992002 | pointe scientific, inc | AUTOHDL CHOLESTEROL REAGENT SET | August 5, 1999 |
| K991789 | elan holdings | ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS | July 9, 1999 |
| K990247 | polymer technology systems | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | May 28, 1999 |
| K984303 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT | January 28, 1999 |
| K980772 | diagnostic chemicals | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 | April 27, 1998 |
| K980770 | diagnostic chemicals | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | April 21, 1998 |
| K974733 | boehringer mannheim | BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL | January 26, 1998 |
| K973369 | roche diagnostic systems | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | November 21, 1997 |
| K971573 | genzyme | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME | June 18, 1997 |
| K962723 | trace america | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN | March 13, 1997 |
| K962186 | genzyme | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | August 19, 1996 |
| K954179 | schiapparelli biosystems | HDL PRECIPITATING REAGENT | December 11, 1995 |
| K944975 | reference diagnostics | MAGNETIC HDL CHOLESTEROL TEST | August 2, 1995 |
| K941744 | merchant house scientific | PBI PLUS HDL PRECIPITATING REAGENT | September 6, 1994 |