510(k) K083052
K083052 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)". The FDA issued a decision of Substantially Equivalent on July 28, 2009. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2009
- Date Received
- October 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibodies, Gliadin
- Device Class
- Class II
- Regulation Number
- 866.5750
- Review Panel
- IM
- Submission Type