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510(k) K170147

Lucica Glycated Albumin-L by Asahi Kasei Pharma Corporation — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2017
Date Received
January 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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