Automated Blood Grouping And Antibody Test Systems

System, Test, Automated Blood Grouping And Antibody

Micro Typing Systems Inc.

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

Pre-market Notification Details

Device IDBK160061
510k NumberBK160061
Device Name:Automated Blood Grouping And Antibody Test Systems
ClassificationSystem, Test, Automated Blood Grouping And Antibody
Applicant Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach,  FL  33069
Product CodeKSZ  
CFR Regulation Number864.9175 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-06-28
Decision Date2016-10-21

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