510(k) K935612 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Nov 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.