Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Gamma Biologicals, Inc.

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

Pre-market Notification Details

Device IDBK850001
510k NumberBK850001
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Gamma Biologicals, Inc. 3700 Mangum Road Houston,  TX  77092
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-26
Decision Date1985-04-05

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