The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Hep-2000 Colorzyme Ana-ro Test System, Model 4200-ro.
| Device ID | K983924 |
| 510k Number | K983924 |
| Device Name: | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 9779 BUSINESS PARK DR. SUITE D Sacramento, CA 95827 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-04 |
| Decision Date | 1998-12-18 |
| Summary: | summary |