510(k) K234052
K234052 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access Ferritin". The FDA issued a decision of Substantially Equivalent on March 20, 2024. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2024
- Date Received
- December 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- CH
- Submission Type