The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Relisa Ana Screening Test System, Model 7096-11.
| Device ID | K992041 |
| 510k Number | K992041 |
| Device Name: | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 2280 SPRINGLAKE RD. SUITE 106 Dallas, TX 75234 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-17 |
| Decision Date | 1999-07-23 |
| Summary: | summary |