Kit, Quality Control For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

North American Biologicals, Inc.

The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK920015
510k NumberBK920015
Device Name:Kit, Quality Control For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant North American Biologicals, Inc. 16500 N.w. 15th Avenue Miami,  FL  33169
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-22
Decision Date1993-05-20

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