K180202 is an FDA 510(k) clearance for the Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts. This device is classified as a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBL).
Submitted by Immuno Concepts, N.A. , Ltd. (Sacramento, US). The FDA issued a Cleared decision on October 19, 2018, 268 days after receiving the submission on January 24, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K180202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2018 |
| Decision Date | October 19, 2018 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBL - Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |