510(k) K012393
K012393 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT TRANSFERRIN VER.2". The FDA issued a decision of Substantially Equivalent on September 19, 2001. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2001
- Date Received
- July 27, 2001
- 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