OPUS CK-MB & TOTAL CK CONTROLS

Enzyme 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 Ck-mb & Total Ck Controls.

Pre-market Notification Details

Device IDK960275
510k NumberK960275
Device Name:OPUS CK-MB & TOTAL CK CONTROLS
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactNancy M Joansen
CorrespondentNancy M Joansen
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-19
Decision Date1996-04-25
Summary:summary

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