510(k) K050596
K050596 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "QUANTIA A1-AT". The FDA issued a decision of Substantially Equivalent on May 13, 2005. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Biokit, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2005
- Date Received
- March 8, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5130
- Review Panel
- IM
- Submission Type