STANDARD HUMAN PLASMA

System, Multipurpose For In Vitro Coagulation Studies

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK924393
510k NumberK924393
Device Name:STANDARD HUMAN PLASMA
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJoseph Kiceina
CorrespondentJoseph Kiceina
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-31
Decision Date1992-11-16

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