510(k) K062203
K062203 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT D-DIMER TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 14, 2007. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2007
- Date Received
- August 1, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrin Split Products
- Device Class
- Class II
- Regulation Number
- 864.7320
- Review Panel
- HE
- Submission Type