OPUS HLH

Radioimmunoassay, Luteinizing Hormone

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK962866
510k NumberK962866
Device Name:OPUS HLH
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactRuth Forstadt
CorrespondentRuth Forstadt
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-23
Decision Date1996-08-23
Summary:summary

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