510(k) K981377 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
ACE T4 REAGENT T4 CALIBRATORS
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Jun 10, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981377
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.