510(k) K190495
K190495 is an FDA 510(k) premarket notification submitted by Biosystems S.A. for the device "Transferrin". The FDA issued a decision of Substantially Equivalent on March 16, 2020. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Biosystems S.A. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2020
- Date Received
- February 28, 2019
- 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