URISCAN OPTIMA— 510(k) K141874

Substantially Equivalent

Yd Diagnostics Corp.

FDA 510(k) clearance K141874 for URISCAN OPTIMA, Substantially Equivalent on 2015-05-28. Applicant: Yd Diagnostics Corp..

Clearance details

Applicant: Yd Diagnostics Corp.
Product code: Code KQO
Advisory panel: Clinical Chemistry
Date received: 2014-07-11
Decision date: 2015-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangnam-Gu, KR

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