510(k) K981312 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 5, 1998 |
| Received | Apr 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981312
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.