510(k) K013206
K013206 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT APOLIPOPROTEIN B VER.2". The FDA issued a decision of Substantially Equivalent on November 16, 2001. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2001
- Date Received
- September 25, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- IM
- Submission Type