CLIBRATION PLASMAS

Plasma, Coagulation Control

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK924404
510k NumberK924404
Device Name:CLIBRATION PLASMAS
ClassificationPlasma, Coagulation Control
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJoseph Kiceina
CorrespondentJoseph Kiceina
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeGGN  
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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