510(k) K012286 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 8, 2001 |
| Received | Jul 20, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. HDL-Cholesterol plus gen.3.; and Small Supersized
Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol con Terminated |
LBS | None listed |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190.
An in-vitro diagnostic reagent system intended for us Terminated |
LBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.