510(k) K810963 ยท JIS Calibrator, Primary
BIO SET TM SUBSTRATE CALIBRATORS
| Applicant | Boehringer Mannheim Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 17, 1981 |
| Received | Apr 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810963
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.