510(k) K031824 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
COBAS INTEGRA CHOLESTEROL GEN. 2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 9, 2003 |
| Received | Jun 13, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031824
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Cholesterol Gen.2.
The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and coba Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.