510(k) K042651 ยท JIT Calibrator, Secondary
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 5, 2004 |
| Received | Sep 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2011 | Beckman Coulter Inc. Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.