The following data is part of a premarket notification filed by Pb Diagnostics, Inc. with the FDA for Opus Serology Controls.
| Device ID | K925703 |
| 510k Number | K925703 |
| Device Name: | OPUS SEROLOGY CONTROLS |
| Classification | Kit, Serological, Positive Control |
| Applicant | PB DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | M Johansen |
| Correspondent | M Johansen PB DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | MJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-04-08 |