CONTROL PLASMA P

Control, Plasma, Abnormal

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK924405
510k NumberK924405
Device Name:CONTROL PLASMA P
ClassificationControl, Plasma, Abnormal
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJoseph Kiceina
CorrespondentJoseph Kiceina
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-31
Decision Date1992-12-01

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