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Blood Establishment Computer Software And Accessories

Carter BloodCare

The following data is part of a premarket notification filed by Carter Bloodcare 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 IDBK180246
510k NumberBK180246
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 Carter BloodCare 2205 Highway 121 Bedford,  TX  76021 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-17
Decision Date2018-11-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857222008006 BK180246 0

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