The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Colorzyme Ebv Early Antigen Igg Antibody Test Sys.
| Device ID | K912489 |
| 510k Number | K912489 |
| Device Name: | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS |
| Classification | Epstein-barr Virus, Other |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Eric S Hoy |
| Correspondent | Eric S Hoy IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-07-24 |