510(k) K223590
K223590 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Folate Assay". The FDA issued a decision of Substantially Equivalent on August 23, 2023. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2023
- Date Received
- December 1, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type