The following data is part of a premarket notification filed by Rhigene, Inc. with the FDA for Rhigene Mesacup2 Test- Scl-70.
| Device ID | K000750 |
| 510k Number | K000750 |
| Device Name: | RHIGENE MESACUP2 TEST- SCL-70 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60068 |
| Contact | Dave Kolesar |
| Correspondent | Dave Kolesar RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60068 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-08 |
| Decision Date | 2000-05-09 |