510(k) K934544 ยท CEC Radioimmunoassay, Free Thyroxine
AXSYM FREE THYROXINE ( FREE T4 )
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Sep 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2003 | Abbott Laboratories HPD/ADD Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.