The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Detectadot System 2000 Heterophile Test.
| Device ID | K895891 |
| 510k Number | K895891 |
| Device Name: | DETECTADOT SYSTEM 2000 HETEROPHILE TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford,phd |
| Correspondent | Fred W Rachford,phd GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1989-10-31 |