The following data is part of a premarket notification filed by Immuno Concepts, Na, Ltd. with the FDA for Image Navigator By Immuno Concepts.
| Device ID | K160265 |
| 510k Number | K160265 |
| Device Name: | Image Navigator By Immuno Concepts |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | Immuno Concepts, NA, Ltd. 9825 Goethe Road; Suite 350 Sacramento, CA 95827 |
| Contact | Eric S. Hoy |
| Correspondent | Eric S. Hoy Immuno Concepts, NA, Ltd. 9825 Goethe Road; Suite 350 Sacramento, CA 95827 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M749IN2201 | K160265 | 000 |
| M749IN1101 | K160265 | 000 |