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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K170147
Device Name Lucica Glycated Albumin-L
Applicant
ASAHI KASEI PHARMA CORPORATION
1-105 KANDA JINBOCHO
CHIYODA-KU
TOKYO,  JP 101-8101
Applicant Contact HIDEJI HIRAOKA
Correspondent
QUINTILESIMS
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact CHRIS SLOAN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received01/17/2017
Decision Date 10/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02489773
Reviewed by Third Party No
Combination Product No
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