LYPHOCHEK HEMOSTASIS CONTROL

Plasma, Coagulation Control

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Hemostasis Control.

Pre-market Notification Details

Device IDK040275
510k NumberK040275
Device Name:LYPHOCHEK HEMOSTASIS CONTROL
ClassificationPlasma, Coagulation Control
Applicant BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618
ContactElizabeth Platt
CorrespondentElizabeth Platt
BIO-RAD 9500 JERONIMO RD. Irvine,  CA  92618
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-05
Decision Date2004-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661001898 K040275 000
00847661001041 K040275 000
00847661001034 K040275 000
00847661001027 K040275 000

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