510(k) K240987
K240987 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access sTfR". The FDA issued a decision of Substantially Equivalent on July 3, 2024. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2024
- Date Received
- April 10, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transferrin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5880
- Review Panel
- IM
- Submission Type