The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Rubella Igg Elisa Test.
| Device ID | K901635 |
| 510k Number | K901635 |
| Device Name: | RUBELLA IGG ELISA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-09 |
| Decision Date | 1990-06-28 |