510(k) K040885
K040885 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE GP210 ELISA". The FDA issued a decision of Substantially Equivalent on June 25, 2004. The device falls under product code NRI (Autoantibodies, Nuclear Pore Glycoprotein Gp210), a Class II device regulated under 21 CFR 866.5090. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2004
- Date Received
- April 5, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Nuclear Pore Glycoprotein Gp210
- Device Class
- Class II
- Regulation Number
- 866.5090
- Review Panel
- IM
- Submission Type
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.