The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Anti-respiratory Syncytial Virus Antibody Test.
| Device ID | K882687 |
| 510k Number | K882687 |
| Device Name: | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| 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 | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-30 |
| Decision Date | 1988-08-30 |