The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Detectadot (tm) System 2000 Toxo Igm Test.
| Device ID | K893200 |
| 510k Number | K893200 |
| Device Name: | DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford |
| Correspondent | Fred W Rachford 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 | 1989-04-26 |
| Decision Date | 1989-12-18 |