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Blood Establishment Computer Software And Accessories

BioLife Plasma Services LP

The following data is part of a premarket notification filed by Biolife Plasma Services Lp 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 IDBK140164
510k NumberBK140164
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
ClassificationBlood Establishment Computer Software And Accessories
Applicant BioLife Plasma Services LP one Baxter Parkway Deerfield,  IL  60015
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-04
Decision Date2014-10-20

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