FDA 510(k)

Diazyme 1,5-AG Assay

K-Number: K180209 · 2018-10-04

Decision Date2018-10-04

Product CodeNOZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Diazyme 1,5-AG Assay is a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2018-10-04 under approval number K180209. The device is classified under product code NOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme 1,5-AG Assay?

Diazyme 1,5-AG Assay is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K180209.

When was Diazyme 1,5-AG Assay approved by the FDA?

Diazyme 1,5-AG Assay received FDA 510(k) clearance on 2018-10-04, under approval number K180209.

What company makes Diazyme 1,5-AG Assay?

Diazyme 1,5-AG Assay is manufactured by Diazyme Laboratories, Inc..

What is the FDA product code for Diazyme 1,5-AG Assay?

The FDA product code for Diazyme 1,5-AG Assay is NOZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.