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Lectins And Protectins

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 IDBK830018
510k NumberBK830018
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
ClassificationLectins And Protectins
Applicant Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross,  GA  30091
Product CodeKSI  
CFR Regulation Number864.9550 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-10-18
Decision Date1983-11-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234000952 BK830018 0

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