510(k) K897193 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
OPUS T4 TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Mar 19, 1990 |
| Received | Dec 29, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897193
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.