skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)— 510(k) K173127

Substantially Equivalent

Skyla Corporation H.S.P.B

FDA 510(k) clearance K173127 for skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit), Substantially Equivalent on 2018-09-25. Applicant: Skyla Corporation H.S.P.B.

Clearance details

Applicant: Skyla Corporation H.S.P.B
Product code: Code LCP
Advisory panel: Hematology
Date received: 2017-09-29
Decision date: 2018-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

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