510(k) K000471 ยท CEW Radioimmunoassay, Parathyroid Hormone
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
| Applicant | Future Diagnostics B.V., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 11, 2000 |
| Received | Feb 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000471
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2023 | Future Diagnostics Solutions B.V. Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic. Open, Classified |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.