K201956 is an FDA 510(k) clearance for the Zeus IFA ANA HEp-2 Test System, Zeus dIFine. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 29, 2022, 654 days after receiving the submission on July 14, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K201956 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2020 |
| Decision Date | April 29, 2022 |
| Days to Decision | 654 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |