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 |