The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Ebv-vca Igm Antibody Test System (enzyme).
| Device ID | K880884 |
| 510k Number | K880884 |
| Device Name: | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Don W Valencia |
| Correspondent | Don W Valencia IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-02 |
| Decision Date | 1988-08-30 |