510(k) K050493
K050493 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "QUANTIA IGE". The FDA issued a decision of Substantially Equivalent on Aug 16, 2005. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Biokit, S.A. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2005
- Date Received
- Feb 28, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ige, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type
- 510(k)