The following data is part of a premarket notification filed by Rhigene, Inc. with the FDA for Mesacup-2 Test Jo-1, Model 10756.
| Device ID | K033528 |
| 510k Number | K033528 |
| Device Name: | MESACUP-2 TEST JO-1, MODEL 10756 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | RHIGENE, INC. 12061 TEJON ST. Westminster, CO 80234 |
| Contact | Nanci Dexter |
| Correspondent | Nanci Dexter RHIGENE, INC. 12061 TEJON ST. Westminster, CO 80234 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-07 |
| Decision Date | 2003-12-22 |
| Summary: | summary |