The following data is part of a premarket notification filed by Immuno Concepts, Na, Ltd. with the FDA for Histofluor Rodent Lks Fluorescent Antibody Test System, Image Navigator By Immuno Concepts.
| Device ID | K180202 |
| 510k Number | K180202 |
| Device Name: | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator By Immuno Concepts |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | Immuno Concepts, NA, Ltd. 9825 Goethe Rd., Suite 350 Sacramento, CA 95827 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy Immuno Concepts, NA, Ltd. 9825 Goethe Rd., Suite 350 Sacramento, CA 95827 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-10-19 |