510(k) K012287 ยท MRR System, Test, Low Density, Lipoprotein
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | Jul 20, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. LDL-Cholesterol gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. Terminated |
MRR | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322.
An in-vitro diagnostic reagent system intended for us Terminated |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.