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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 K133803
Device Name DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/16/2013
Decision Date 08/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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