510(k) K051804 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL80 FLEX ANALYZER
| Applicant | Sendx Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 1, 2005 |
| Received | Jul 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2020 | Radiometer Medical ApS ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | None listed |
| Aug 30, 2012 | Sendx Medical Inc ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System.
Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with Terminated |
CHL | None listed |
| Apr 9, 2012 | Sendx Medical Inc SenDx Medical Inc
ABL80FLEX
Blood Gas, pH, Electrolyte, and Metabolite System
The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit Terminated |
CHL | None listed |
| Aug 29, 2007 | Sendx Medical Inc ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.