510(k) K853009 ยท JSS Kit, Identification, Enterobacteriaceae
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, Mar 4, 1986 |
| Received | Jul 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853009
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.