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AU BICARBONATE REAGENT

FDA 510(k) clearance K131546 · decided 2013-10-09

Clearance details

K-number
K131546
Device name
AU BICARBONATE REAGENT
Applicant
Beckman Coulter Ireland, Inc.
Decision
Substantially Equivalent
Date received
2013-05-29
Decision date
2013-10-09
Days to decision
133 days
Clearance type
Traditional
Product code
KHS
Device class
2
Regulation number
862.1160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system r recall (Z-0997-2026)Beckman Coulter Ireland, Inc.2025-12-23
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL recall (Z-1606-2023)Beckman Coulter Inc.2023-05-18
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL recall (Z-1607-2023)Beckman Coulter Inc.2023-05-18
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL recall (Z-1608-2023)Beckman Coulter Inc.2023-05-18