510(k) K060295 ยท KHS Enzymatic, Carbon-Dioxide
CARBON DIOXIDE
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Feb 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2019 | Abbott GmBH & Co. KG Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada Terminated |
KHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.