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 |
M74900IN2201 | K160265 | 000 |
M74900IN1101 | K160265 | 000 |