510(k) K971203 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
SYNCHRON SYSTEMS THYROXINE REAGENT
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 16, 1997 |
| Received | Apr 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971203
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.