The following data is part of a premarket notification filed by Fuller Laboratories, Inc. with the FDA for Meridian Ebv-igg Test Kit.
| Device ID | K925689 |
| 510k Number | K925689 |
| Device Name: | MERIDIAN EBV-IGG TEST KIT |
| Classification | Antigen, Ebv, Capsid |
| Applicant | FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton, CA 92631 |
| Contact | Lee Fuller |
| Correspondent | Lee Fuller FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton, CA 92631 |
| Product Code | MCD |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-10-12 |