The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Rhigene Hep-ana Test System.
| Device ID | K042680 |
| 510k Number | K042680 |
| Device Name: | RHIGENE HEP-ANA TEST SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CORGENIX, INC. 455 STATE STREET Des Plaines, IL 60016 |
| Contact | Yusuke Kobe |
| Correspondent | Yusuke Kobe CORGENIX, INC. 455 STATE STREET Des Plaines, IL 60016 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-11-19 |
| Summary: | summary |