A1c iGear System— 510(k) K142789

Substantially Equivalent

Sakae Corporation

FDA 510(k) clearance K142789 for A1c iGear System, Substantially Equivalent on 2014-12-16. Applicant: Sakae Corporation. Device class: 2.

Clearance details

Applicant: Sakae Corporation
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2014-09-26
Decision date: 2014-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fujioka, Gunma, JP

Download summary PDF View on FDA.gov ↗

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