AUTOMATED 8400 BLOOD CELL SEPARATOR

Separator, Automated, Blood Cell And Plasma, Therapeutic

INTL. BUSINESS MACHINES

The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Automated 8400 Blood Cell Separator.

Pre-market Notification Details

Device IDK831004
510k NumberK831004
Device Name:AUTOMATED 8400 BLOOD CELL SEPARATOR
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant INTL. BUSINESS MACHINES 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-29
Decision Date1983-09-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35020583707000 K831004 000
05020583707009 K831004 000

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