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 |