Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test— 510(k) K142754

Name: FDA 510(k) clearance K142754
Creator: U.S. Food and Drug Administration
Published: 2016-04-07

Substantially Equivalent

Sugentech, Inc.

FDA 510(k) clearance K142754 for Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test, Substantially Equivalent on 2016-04-07. Applicant: Sugentech, Inc.. Device class: 2.

Clearance details

Applicant: Sugentech, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2014-09-25
Decision date: 2016-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

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