510(k) K080166 ยท JIT Calibrator, Secondary
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 19, 2008 |
| Received | Jan 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080166
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.