Automated Blood Cell Separator -Filtration

Separator, Automated, Blood Cell, Diagnostic

Cobe Laboratories, Inc.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Automated Blood Cell Separator -filtration.

Pre-market Notification Details

Device IDBK840009
510k NumberBK840009
Device Name:Automated Blood Cell Separator -Filtration
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Cobe Laboratories, Inc. 1185 Oak Street Lakewood,  CO  80215
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-19
Decision Date1984-06-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.