510(k) K061382 ยท JZO System, Test, Thyroid Autoantibody
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | May 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061382
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.