Steripath Gen2 Blood Collection System

Tubes, Vials, Systems, Serum Separators, Blood Collection

Magnolia Medical Technologies, Inc.

The following data is part of a premarket notification filed by Magnolia Medical Technologies, Inc. with the FDA for Steripath Gen2 Blood Collection System.

Pre-market Notification Details

Device IDK192247
510k NumberK192247
Device Name:Steripath Gen2 Blood Collection System
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle,  WA  98119
ContactGregory J Bullington
CorrespondentJohn Ray
Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle,  WA  98119
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-02-28

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