510(k) K061683
K061683 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2006
- Date Received
- June 15, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Myoglobin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5680
- Review Panel
- IM
- Submission Type