510(k) K946119 ยท LAS Drug Specific Control Materials
ROCHE-TDM ONLEIN(TM) CONTROLS
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Feb 7, 1995 |
| Received | Dec 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946119
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.