Kit, Quality Control For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK040014
510k NumberBK040014
Device Name:Kit, Quality Control For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-03
Decision Date2004-04-22

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