The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Immunoassay System.
| Device ID | K894159 |
| 510k Number | K894159 |
| Device Name: | OPUS IMMUNOASSAY SYSTEM |
| Classification | Fluorometer, For Clinical Use |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Deborah Grabbe |
| Correspondent | Deborah Grabbe PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-14 |
| Decision Date | 1989-08-03 |