510(k) K942048 ยท DKB Calibrators, Drug Mixture
ROCHE AMMONIA (VARIOUS)
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Oct 4, 1994 |
| Received | Apr 28, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942048
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.