Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Automated Blood Cell Separators.

Pre-market Notification Details

Device IDBK020059
510k NumberBK020059
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Baxter Healthcare Corporation 25212 West Ill Route 120 Roundlake,  IL  60073
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-20
Decision Date2003-01-23

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