Access anti-HBc Total— 510(k) K253687
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K253687 for Access anti-HBc Total, Substantially Equivalent on 2026-02-19. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code SEI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3173
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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