Access Ostase— 510(k) K232904
Substantially EquivalentBeckman Coulter
FDA 510(k) clearance K232904 for Access Ostase, Substantially Equivalent on 2024-04-15. Applicant: Beckman Coulter. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter
- Product code
- Code CIN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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