FDA 510(k) Applications for Medical Device Product Code "NOZ"
(Assay, 1,5-Anhydroglucitol (15ag))

FDA 510(k) Number Applicant Device Name Decision Date
K180209 Diazyme Laboratories Inc. Diazyme 1,5-AG Assay 10/04/2018
K031604 TOMEN AMERICA INC. GLYCOMARK 09/22/2003


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