510(k) K092399
K092399 is an FDA 510(k) premarket notification submitted by Orgentec Diagnostika GmbH for the device "ANTI-MUTATED CITRULLINATED VIMENTIN EIA". The FDA issued a decision of Substantially Equivalent on July 1, 2010. The device falls under product code OQZ (Anti-Mutated Citrullinated Vimentin Igg), a Class II device regulated under 21 CFR 866.5775. Orgentec Diagnostika GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2010
- Date Received
- August 6, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Mutated Citrullinated Vimentin Igg
- Device Class
- Class II
- Regulation Number
- 866.5775
- Review Panel
- IM
- Submission Type
For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.