510(k) K091520
K091520 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on March 10, 2010. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2010
- Date Received
- May 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Endomysial(Tissue Transglutaminase)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type