The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Monabrite Respir Syncytial Virus(rsv) Test Kit.
| Device ID | K861379 |
| 510k Number | K861379 |
| Device Name: | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT |
| Classification | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Applicant | SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Product Code | LKT |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-14 |
| Decision Date | 1986-07-16 |