K897025 is an FDA 510(k) clearance for the ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM. 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 January 2, 1990, 14 days after receiving the submission on December 19, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K897025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1989 |
| Decision Date | January 02, 1990 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |