The following data is part of a premarket notification filed by Rhigene, Inc. with the FDA for Mesacup Test Pr-3.
| Device ID | K040711 |
| 510k Number | K040711 |
| Device Name: | MESACUP TEST PR-3 |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| 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 | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-18 |
| Decision Date | 2004-04-02 |
| Summary: | summary |