The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Lyme Igm Elisa Test.
| Device ID | K903013 |
| 510k Number | K903013 |
| Device Name: | LYME IGM ELISA TEST |
| Classification | Reagent, Borrelia Serological Reagent |
| 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 | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1991-06-21 |