510(k) K160265
K160265 is an FDA 510(k) premarket notification submitted by Immuno Concepts, N.A. , Ltd. for the device "Image Navigator by Immuno Concepts". The FDA issued a decision of Substantially Equivalent on June 17, 2016. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immuno Concepts, N.A. , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2016
- Date Received
- February 2, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type