510(k) K112223
K112223 is an FDA 510(k) premarket notification submitted by Euroimmun US for the device "EUROIMMUN ANTI-LKM-1 ELISA(LGG)". The FDA issued a decision of Substantially Equivalent on September 11, 2012. The device falls under product code NBS (Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)), a Class II device regulated under 21 CFR 866.5660. Euroimmun US has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2012
- Date Received
- August 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type