Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Fujirebio Diagnostics, Inc.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.

Pre-market Notification Details

Device IDBK070030
510k NumberBK070030
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern,  PA  19355 US
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-06
Decision Date2007-09-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850212007058 BK070030 0
04987270227541 BK070030 0

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