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Supplies, Blood-bank

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK880022
510k NumberBK880022
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationSupplies, Blood-bank
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-03
Decision Date1989-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234001287 BK880022 0
10888234001560 BK880022 0

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