510(k) K963292 ยท CIC Cresolphthalein Complexone, Calcium
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Oct 31, 1996 |
| Received | Aug 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2011 | Roche Diagnostics Operations, Inc. Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN.
For the in Terminated |
CIC | None listed |
| Mar 25, 2011 | Roche Diagnostics Operations, Inc. Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190, Roche Diagnostics Corporation, Indianapolis, IN.
For the in vitro quantitative determination of calcium in serum, Terminated |
CIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.