510(k) K153651 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 18, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153651
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.