OPUS PSA TEST SYSTEM

Prostate-specific Antigen (psa) For Management Of Prostate Cancers

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Psa Test System.

Pre-market Notification Details

Device IDK964595
510k NumberK964595
Device Name:OPUS PSA TEST SYSTEM
ClassificationProstate-specific Antigen (psa) For Management Of Prostate Cancers
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactKathleen Dray-lyons
CorrespondentKathleen Dray-lyons
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeLTJ  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-18
Decision Date1997-06-24
Summary:summary

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