510(k) K022746 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Nov 22, 2002 |
| Received | Aug 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2009 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer
Catalog # 35238
Intended for in vitro diagnostic use by health care professionals and for point-of-care Terminated |
CGL | None listed |
| Feb 28, 2006 | Nova Biomedical Corporation Stat Profile Critical Care PLUS (CCX) Analyzer
Catalog Number: 37413 Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX) Analyzer
Catalog Number: 35942 Terminated |
CHL | None listed |
| Oct 24, 2003 | Nova Biomedical Corporation Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer)
Part # 37271 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.