Test, Donor, CMV

Test, Donor, Cmv

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Test, Donor, Cmv.

Pre-market Notification Details

Device IDBK950029
510k NumberBK950029
Device Name:Test, Donor, CMV
ClassificationTest, Donor, Cmv
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeMZE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-03
Decision Date1995-12-22

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