The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Ebv-ea(d) Igg Elisa Test.
| Device ID | K940093 |
| 510k Number | K940093 |
| Device Name: | EBV-EA(D) IGG ELISA TEST |
| Classification | Epstein-barr Virus, Other |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford, Ph.d |
| Correspondent | Fred W Rachford, Ph.d GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1995-09-15 |