510(k) K002609
K002609 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 2000. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2000
- Date Received
- August 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Rheumatoid Factor
- Device Class
- Class II
- Regulation Number
- 866.5775
- Review Panel
- IM
- Submission Type