Lucica Glycated Albumin-L— 510(k) K170147

Name: FDA 510(k) clearance K170147
Creator: U.S. Food and Drug Administration
Published: 2017-10-12

Substantially Equivalent

Asahi Kasei Pharma Corporation

FDA 510(k) clearance K170147 for Lucica Glycated Albumin-L, Substantially Equivalent on 2017-10-12. Applicant: Asahi Kasei Pharma Corporation. Device class: 2.

Clearance details

Applicant: Asahi Kasei Pharma Corporation
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2017-01-17
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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