510(k) K103484 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
GSP NEONATAL THYROXINE (T4)
| Applicant | Wallac Oy, A Subsidiary of Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 22, 2011 |
| Received | Nov 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103484
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.