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

Name: FDA 510(k) clearance K173127
Creator: U.S. Food and Drug Administration
Published: 2018-09-25

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. Device class: 2.

Clearance details

Applicant: Skyla Corporation H.S.P.B
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2017-09-29
Decision date: 2018-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

Download summary PDF View on FDA.gov ↗

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