The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Pathfinder(tm) Respiratory Syncytial Virus.
| Device ID | K862743 |
| 510k Number | K862743 |
| Device Name: | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | KALLESTAD LABORATORIES, INC. 2000 INTERFIRST TOWER Austin, TX 78701 |
| Contact | Susan U Neill |
| Correspondent | Susan U Neill KALLESTAD LABORATORIES, INC. 2000 INTERFIRST TOWER Austin, TX 78701 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-21 |
| Decision Date | 1986-09-29 |