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

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..

Clearance details

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

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