TAP Blood Collection Device— 510(k) K190225

Name: FDA 510(k) clearance K190225
Creator: U.S. Food and Drug Administration
Published: 2019-11-05

Substantially Equivalent

Seventh Sense Biosystems, Inc.

FDA 510(k) clearance K190225 for TAP Blood Collection Device, Substantially Equivalent on 2019-11-05. 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: 2019-02-05
Decision date: 2019-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PRJ

view all

K161521 — TAP Blood Collection Device2017-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.