510(k) K943999 ยท DIF Drug Mixture Control Materials
ABUSCREEN ONTRAK POSITIVE CONTROL
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Jan 25, 1995 |
| Received | Jul 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943999
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.