The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Relisa Ena Antibody Screening Test System.
| Device ID | K935129 |
| 510k Number | K935129 |
| Device Name: | RELISA ENA ANTIBODY SCREENING TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Contact | Eric S Hoy, Ph.d |
| Correspondent | Eric S Hoy, Ph.d IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-01-31 |