510(k) K896329 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
| Applicant | Photec Diagnostics, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 12, 1989 |
| Received | Nov 2, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896329
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.