510(k) K032458 ยท JIT Calibrator, Secondary
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 6, 2003 |
| Received | Aug 11, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. Terminated |
JIT | None listed |
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.