Albumin BCP
K-Number: K193001 · 2019-12-19
ApplicantSENTINEL CH. SpA
Decision Date2019-12-19
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Albumin BCP is a medical device manufactured by SENTINEL CH. SpA. It received FDA 510(k) clearance on 2019-12-19 under approval number K193001. 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 BCP?
Albumin BCP is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by SENTINEL CH. SpA. The 510(k) number is K193001.
When was Albumin BCP approved by the FDA?
Albumin BCP received FDA 510(k) clearance on 2019-12-19, under approval number K193001.
What company makes Albumin BCP?
Albumin BCP is manufactured by SENTINEL CH. SpA.
What is the FDA product code for Albumin BCP?
The FDA product code for Albumin BCP is CJW.
Other Devices by SENTINEL CH. SpA
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.