510(k) K163177
K163177 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA". The FDA issued a decision of Substantially Equivalent on July 28, 2017. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2017
- Date Received
- November 14, 2016
- 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