510(k) K851032 ยท KXT Enzyme Immunoassay, Digoxin
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, Apr 3, 1985 |
| Received | Mar 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2007 | Roche Diagnostics Corp. Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322. Terminated |
KXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.