Albumin BCG2
K-Number: K203248 · 2021-11-23
ApplicantAbbott Ireland Diagnostics Division
Decision Date2021-11-23
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Albumin BCG2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2021-11-23 under approval number K203248. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Albumin BCG2?
Albumin BCG2 is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K203248.
When was Albumin BCG2 approved by the FDA?
Albumin BCG2 received FDA 510(k) clearance on 2021-11-23, under approval number K203248.
What company makes Albumin BCG2?
Albumin BCG2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Albumin BCG2?
The FDA product code for Albumin BCG2 is CIX.
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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.