Capture-CMV

Antigen, Iha, Cytomegalovirus

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Capture-cmv.

Pre-market Notification Details

Device IDK183571
510k NumberK183571
Device Name:Capture-CMV
ClassificationAntigen, Iha, Cytomegalovirus
Applicant Immucor, Inc. 3130 Gateway Drive Norcross,  GA  30071
ContactHoward Yorek
CorrespondentHoward Yorek
Immucor, Inc. 3130 Gateway Drive Norcross,  GA  30071
Product CodeLJO  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-02-04
Summary:summary

Trademark Results [Capture-CMV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPTURE-CMV
CAPTURE-CMV
74179110 1695744 Live/Registered
IMMUCOR, INC.
1991-06-24

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