The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Detectadot(tm) System 2000 Rubella Igg Test.
| Device ID | K892202 |
| 510k Number | K892202 |
| Device Name: | DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-09-13 |