Access Folate Assay— 510(k) K223590
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K223590 for Access Folate Assay, Substantially Equivalent on 2023-08-23. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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