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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 K160762
Device Name Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
Applicant
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Applicant Contact ABHIJIT DATTA
Correspondent
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Correspondent Contact ABHIJIT DATTA
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received03/21/2016
Decision Date 11/21/2016
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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