OPUS HCG CONTROLS

Single (specified) Analyte Controls (assayed And Unassayed)

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK954144
510k NumberK954144
Device Name:OPUS HCG CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
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 CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-05
Decision Date1995-10-06

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