AU BICARBONATE REAGENT— 510(k) K131546
Substantially EquivalentBeckman Coulter Ireland, Inc.
FDA 510(k) clearance K131546 for AU BICARBONATE REAGENT, Substantially Equivalent on 2013-10-09. Applicant: Beckman Coulter Ireland, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter Ireland, Inc.
- Product code
- Code KHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code KHS
view allMore clearances from Beckman Coulter Ireland, Inc.
view allRecalls naming K131546
K-number listed on FDA's recall record- Z-0997-2026 — 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 analyzers.
- Z-1606-2023 — Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
- Z-1607-2023 — Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
- Z-1608-2023 — Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131546.
Data sourced from openFDA. This site is unofficial and independent of the FDA.