510(k) K981427 ยท GKF Instrument, Hematocrit, Automated
STAT PROFILE M ANALYZER
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Apr 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2003 | Nova Biomedical Corporation Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer)
Part # 20394 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.