The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Cmv Test System.
| Device ID | K905257 |
| 510k Number | K905257 |
| Device Name: | OPUS CMV TEST SYSTEM |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Dray Lyons |
| Correspondent | Dray Lyons PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-21 |
| Decision Date | 1991-04-17 |