Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Fujirebio Diagnostics, Inc

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc with the FDA for Quality Control Kits For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK960070
510k NumberBK960070
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Fujirebio Diagnostics, Inc 201 Great Valley Parkway Malvern,  PA  19355
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-05
Decision Date1997-06-19

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

A PHP Error was encountered

Severity: Core Warning

Message: Module 'zip' already loaded

Filename: Unknown

Line Number: 0

Backtrace: