510(k) K952148 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
AXSYM ULTRASENSITIVE HTSH II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 29, 1995 |
| Received | May 8, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2008 | Abbott Diagnostic International, Ltd. AxSYM Ultrasensitive hTSH II Master Calibrators
Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma. Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.