510(k) K000535
K000535 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE LKM-1 ELISA". The FDA issued a decision of Substantially Equivalent on June 7, 2000. 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. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2000
- Date Received
- February 17, 2000
- 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