510(k) K012361
K012361 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT COMPLEMENT C3C TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2001
- Date Received
- July 25, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Complement C3, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5240
- Review Panel
- IM
- Submission Type