510(k) K961579 ยท GKP Instrument, Coagulation, Automated
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | Apr 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961579
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2007 | Diagnostica Stago, Inc. STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. Terminated |
GKP | None listed |
| May 16, 2007 | Diagnostica Stago, Inc. STA Compact and STA Compact CT
For in vitro Diagnostic Use Only
In vitro diagnostic analyzer
Diagnostica Stago
France Terminated |
GKP | None listed |
| May 29, 2003 | Diagnostica Stago, Inc. STA-Compact Hemostasis System with Cap piercing capability. Terminated |
GKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.