The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Psa Test System.
| Device ID | K964595 |
| 510k Number | K964595 |
| Device Name: | OPUS PSA TEST SYSTEM |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-06-24 |
| Summary: | summary |