EasyPoint Blood Collection Plus

Tubes, Vials, Systems, Serum Separators, Blood Collection

Retractable Technologies, Inc.

The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Easypoint Blood Collection Plus.

Pre-market Notification Details

Device IDK202325
510k NumberK202325
Device Name:EasyPoint Blood Collection Plus
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Retractable Technologies, Inc. 511 Lobo Lane Little Elm,  TX  75068
ContactBecky Piroga
CorrespondentBecky Piroga
Retractable Technologies, Inc. 511 Lobo Lane Little Elm,  TX  75068
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2021-04-09

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