Blood Bank Supplies

Supplies, Blood-bank

Immucor, Inc.

The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK950017
510k NumberBK950017
Device Name:Blood Bank Supplies
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 Received1995-02-22
Decision Date1997-10-24

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