510(k) K945289 ยท DKB Calibrators, Drug Mixture
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
| Applicant | Medi-Tech, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Dec 13, 1994 |
| Received | Oct 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945289
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.