K001556 is an FDA 510(k) clearance for the HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on August 21, 2000, 95 days after receiving the submission on May 18, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K001556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2000 |
| Decision Date | August 21, 2000 |
| Days to Decision | 95 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 |