OPUS PROCAINAMIDE

Enzyme Immunoassay, Procainamide

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK951434
510k NumberK951434
Device Name:OPUS PROCAINAMIDE
ClassificationEnzyme Immunoassay, Procainamide
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactNancy M Johansen
CorrespondentNancy M Johansen
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeLAR  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-28
Decision Date1995-07-03

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