Kit, Quality Control For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Amtec Diagnostics International Inc.

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

Pre-market Notification Details

Device IDBK850010
510k NumberBK850010
Device Name:Kit, Quality Control For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Amtec Diagnostics International Inc. 1107 Ih-45 South Conroe,  TX  77305
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-19
Decision Date1985-12-27

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