Submission Details
| 510(k) Number | K201956 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
Apr 2022
Decision
654d
Days
Class 2
Risk
About This 510(k) Submission
K201956 is an FDA 510(k) clearance for the Zeus IFA ANA HEp-2 Test System, Zeus dIFine, 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 review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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