Access PCT— 510(k) K222996
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K222996 for Access PCT, Substantially Equivalent on 2023-04-26. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code PTF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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