The following data is part of a premarket notification filed by Rhigene, Inc. with the FDA for Mesacup-2 Test Cenp-b.
| Device ID | K040200 |
| 510k Number | K040200 |
| Device Name: | MESACUP-2 TEST CENP-B |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60016 |
| Contact | Yusuke Kobe |
| Correspondent | Yusuke Kobe RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60016 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-03-04 |
| Summary: | summary |