510(k) K971060 ยท DIF Drug Mixture Control Materials
PRECINORM TDM CONTROLS
| Applicant | Boehringer Mannheim Corp., Concord CA, US |
| Decision | Substantially Equivalent, Jul 7, 1997 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971060
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.