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FDA 510(k) Application Details - K160762
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K160762
Device Name
Assay, Glycosylated Hemoglobin
Applicant
DIAZYME LABORATORIES
12889 GREGG COURT
POWAY, CA 92064 US
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Contact
ABHIJIT DATTA
Other 510(k) Applications for this Contact
Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
03/21/2016
Decision Date
11/21/2016
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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