Processing Systems For Frozen Blood

System, Processing For Frozen Blood

International Business Machines

The following data is part of a premarket notification filed by International Business Machines with the FDA for Processing Systems For Frozen Blood.

Pre-market Notification Details

Device IDBK830003
510k NumberBK830003
Device Name:Processing Systems For Frozen Blood
ClassificationSystem, Processing For Frozen Blood
Applicant International Business Machines Princeton,  NJ  08540
Product CodeKSW  
CFR Regulation Number864.9145 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-28
Decision Date1983-05-27

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