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FDA 510(k)

Diazyme EZ Vitamin D Assay

K-Number: K172992 · 2018-01-11

ApplicantDiazyme Laboratories
Decision Date2018-01-11
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diazyme EZ Vitamin D Assay is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2018-01-11 under approval number K172992. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme EZ Vitamin D Assay?

Diazyme EZ Vitamin D Assay is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Diazyme Laboratories. The 510(k) number is K172992.

When was Diazyme EZ Vitamin D Assay approved by the FDA?

Diazyme EZ Vitamin D Assay received FDA 510(k) clearance on 2018-01-11, under approval number K172992.

What company makes Diazyme EZ Vitamin D Assay?

Diazyme EZ Vitamin D Assay is manufactured by Diazyme Laboratories.

What is the FDA product code for Diazyme EZ Vitamin D Assay?

The FDA product code for Diazyme EZ Vitamin D Assay is MRG.

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Official Source

View on FDA Database →

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

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