OPUS PROGESTERONE

Radioimmunoassay, Progesterone

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK971725
510k NumberK971725
Device Name:OPUS PROGESTERONE
ClassificationRadioimmunoassay, Progesterone
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactRuth Forstadt
CorrespondentRuth Forstadt
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-09
Decision Date1997-06-18
Summary:summary

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