PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)

Control, Plasma, Abnormal

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Pathoplasma(r) I & Ii (path Citrated Human Plasma).

Pre-market Notification Details

Device IDK924401
510k NumberK924401
Device Name:PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
ClassificationControl, Plasma, Abnormal
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactLori Baranauskas
CorrespondentLori Baranauskas
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-31
Decision Date1994-02-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.