510(k) K131546 ยท KHS Enzymatic, Carbon-Dioxide
AU BICARBONATE REAGENT
| Applicant | Beckman Coulter Ireland, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 9, 2013 |
| Received | May 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2025 | Beckman Coulter Ireland, Inc. BECKMAN COULTER BICARBONATE REF:
OSR6137
OSR6237
OSR6637
OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU anal Open, Classified |
KHS | None listed |
| May 18, 2023 | Beckman Coulter Inc. Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL Open, Classified |
KHS | None listed |
| May 18, 2023 | Beckman Coulter Inc. Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL Open, Classified |
KHS | None listed |
| May 18, 2023 | Beckman Coulter Inc. Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL Open, Classified |
KHS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.