510(k) K013278
K013278 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT APOLIPOPROTEIN A-1 VER.2". The FDA issued a decision of Substantially Equivalent on November 15, 2001. The device falls under product code DEL (Lipoprotein X, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5590. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2001
- Date Received
- October 1, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein X, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5590
- Review Panel
- IM
- Submission Type