510(k) K990377 ยท DIF Drug Mixture Control Materials
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Feb 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990377
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.