Access Ostase
K-Number: K232904 · 2024-04-15
ApplicantBeckman Coulter
Decision Date2024-04-15
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Access Ostase is a medical device manufactured by Beckman Coulter. It received FDA 510(k) clearance on 2024-04-15 under approval number K232904. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Access Ostase?
Access Ostase is a medical device that received FDA 510(k) clearance on 2024-04-15. It is manufactured by Beckman Coulter. The 510(k) number is K232904.
When was Access Ostase approved by the FDA?
Access Ostase received FDA 510(k) clearance on 2024-04-15, under approval number K232904.
What company makes Access Ostase?
Access Ostase is manufactured by Beckman Coulter.
What is the FDA product code for Access Ostase?
The FDA product code for Access Ostase is CIN.
Other Devices by Beckman Coulter
DEN160047ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
K182886Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
K181475DxH 520 Hematology Instrument
Related Devices (Code: CIN)
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.