TAP Blood Collection Device

Capillary Blood Collection Device For Alternative Site Collection

Seventh Sense Biosystems, Inc.

The following data is part of a premarket notification filed by Seventh Sense Biosystems, Inc. with the FDA for Tap Blood Collection Device.

Pre-market Notification Details

Device IDK190225
501k NumberK190225
Device Name:TAP Blood Collection Device
ClassificationCapillary Blood Collection Device For Alternative Site Collection
Applicant Seventh Sense Biosystems, Inc. 200 Boston Avenue, Suite 3700 Medford,  MA  02155
ContactTim Richards
CorrespondentTim Richards
Seventh Sense Biosystems, Inc. 200 Boston Avenue, Suite 3700 Medford,  MA  02155
Product CodePRJ  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
501k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-05
Decision Date2019-11-05

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