510(k) K983417 ยท CEC Radioimmunoassay, Free Thyroxine
ABBOTT ARCHITECT FREE T4
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Sep 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CEC | None listed |
| Aug 13, 2003 | Abbott Laboratories HPD/ADD Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; 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.