510(k) K843913 ยท DIF Drug Mixture Control Materials
COBAS FP TDM CONTROLS
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Oct 30, 1984 |
| Received | Oct 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843913
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.