510(k) K042281 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 16, 2004 |
| Received | Aug 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042281
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.