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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, 1,5-Anhydroglucitol (15ag)
510(k) Number K180209
Device Name Diazyme 1,5-AG Assay
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Court
Poway,  CA  92130
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Court
Poway,  CA  92130
Correspondent Contact Abhijit Datta
Regulation Number864.7470
Classification Product Code
NOZ  
Date Received01/24/2018
Decision Date 10/04/2018
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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