Automated Cell-washing Centrifuge For Immune-hematology

Centrifuge, Cell-washing, Automated For Immuno-hematology

Helmer Inc.

The following data is part of a premarket notification filed by Helmer Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.

Pre-market Notification Details

Device IDBK170141
510k NumberBK170141
Device Name:Automated Cell-washing Centrifuge For Immune-hematology
ClassificationCentrifuge, Cell-washing, Automated For Immuno-hematology
Applicant Helmer Inc. 14400 Bergen Blvd Noblesville,  IN  46060 US
Product CodeKSN  
CFR Regulation Number864.9285 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-15
Decision Date2018-01-22

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