510(k) K093357 ยท JIT Calibrator, Secondary
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
| Applicant | Diamond Diagnostics, Inc., Holliston MA, US |
| Decision | Substantially Equivalent, Jun 24, 2010 |
| Received | Oct 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093357
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.