The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Respiratory Syncytial Virus-.
| Device ID | K841527 |
| 510k Number | K841527 |
| Device Name: | ORTHO RESPIRATORY SYNCYTIAL VIRUS- |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-12 |
| Decision Date | 1984-08-12 |