The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Monabrite Cytomegalovirus (cmv) Ifa Kit.
| Device ID | K864565 |
| 510k Number | K864565 |
| Device Name: | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| 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 | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-19 |
| Decision Date | 1987-02-19 |