The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Detectadot System 2000 Toxo Igg Test.
| Device ID | K875109 |
| 510k Number | K875109 |
| Device Name: | DETECTADOT SYSTEM 2000 TOXO IGG TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Rachford, Phd |
| Correspondent | Rachford, Phd GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-14 |
| Decision Date | 1988-03-07 |