510(k) K052262
K052262 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE M2 EP (MIT3) ELISA". The FDA issued a decision of Substantially Equivalent on October 27, 2005. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), 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
- October 27, 2005
- Date Received
- August 19, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5090
- Review Panel
- IM
- Submission Type