The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Rsv-mab Test.
| Device ID | K912842 |
| 510k Number | K912842 |
| Device Name: | RSV-MAB TEST |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| 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 | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1991-12-09 |