CONTROL PLASMA N

Plasma, Control, Normal

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK924403
510k NumberK924403
Device Name:CONTROL PLASMA N
ClassificationPlasma, Control, Normal
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactLori Baranauskas
CorrespondentLori Baranauskas
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeGIZ  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-31
Decision Date1994-02-22

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