TAP Blood Collection Device— 510(k) K161521

Name: FDA 510(k) clearance K161521
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Substantially Equivalent

Seventh Sense Biosystems, Inc.

FDA 510(k) clearance K161521 for TAP Blood Collection Device, Substantially Equivalent on 2017-02-16. Applicant: Seventh Sense Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Seventh Sense Biosystems, Inc.
Product code: Code PRJ
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2016-06-02
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, MA, US

Download summary PDF View on FDA.gov ↗

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