Albumin BCP2
K-Number: K203530 · 2022-03-18
ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-03-18
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Albumin BCP2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-03-18 under approval number K203530. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Albumin BCP2?
Albumin BCP2 is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K203530.
When was Albumin BCP2 approved by the FDA?
Albumin BCP2 received FDA 510(k) clearance on 2022-03-18, under approval number K203530.
What company makes Albumin BCP2?
Albumin BCP2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Albumin BCP2?
The FDA product code for Albumin BCP2 is CJW.
Other Devices by Abbott Ireland Diagnostics Division
Related Devices (Code: CJW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.