510(k) K180202
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts by
Immuno Concepts, N.A. , Ltd.
— Product Code DBL
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2018
- Date Received
- January 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type