510(k) K915003 ยท DKB Calibrators, Drug Mixture
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Nov 29, 1991 |
| Received | Nov 7, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915003
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.