510(k) K113072
K113072 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations for the device "TINA-QUANT ALBUMIN GEN.2". The FDA issued a decision of Substantially Equivalent on May 14, 2012. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Roche Diagnostics Operations has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2012
- Date Received
- October 17, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Albumin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5040
- Review Panel
- IM
- Submission Type