Diazyme 1,5-AG Assay

Assay, 1,5-anhydroglucitol (15ag)

Diazyme Laboratories Inc.

The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme 1,5-ag Assay.

Pre-market Notification Details

Device IDK180209
510k NumberK180209
Device Name:Diazyme 1,5-AG Assay
ClassificationAssay, 1,5-anhydroglucitol (15ag)
Applicant Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92130
ContactAbhijit Datta
CorrespondentAbhijit Datta
Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92130
Product CodeNOZ  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-24
Decision Date2018-10-04
Summary:summary

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