Blood Bank Supplies

Supplies, Blood-bank

Reagent Laboratory, Inc.

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

Pre-market Notification Details

Device IDBK860034
510k NumberBK860034
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Reagent Laboratory, Inc. 300 East Ottawa Avenue Louisville,  KY  40209
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-08
Decision Date1987-06-01

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