The following data is part of a premarket notification filed by Hyperion, Inc. with the FDA for Visiquant Anti-nuclear Antibody Test System.
| Device ID | K022800 |
| 510k Number | K022800 |
| Device Name: | VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Contact | Radha Goolabsingh |
| Correspondent | Radha Goolabsingh HYPERION, INC. 14100 S.W. 136TH ST. Miami, FL 33186 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-23 |
| Decision Date | 2002-11-25 |
| Summary: | summary |