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FDA 510(k) Application Details - K140827
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K140827
Device Name
Assay, Glycosylated Hemoglobin
Applicant
SD Biosensor, Inc.
C-4th & 5th Floor digital Empire Building 980-3
Yeongtong-dong, Yeongtong-gu
Suwon-si 443-702 KR
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Contact
Yeon Park
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
04/01/2014
Decision Date
09/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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