510(k) K040431
K040431 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2". The FDA issued a decision of Substantially Equivalent on March 10, 2004. The device falls under product code DAO (Igm (Mu Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2004
- Date Received
- February 19, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Igm (Mu Chain Specific), Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type