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FDA 510(k)

Aptiva Celiac Disease IgA Reagent

K-Number: K193604 · 2021-06-16

ApplicantInova Diagnostics, Inc.
Decision Date2021-06-16
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva Celiac Disease IgA Reagent is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-16 under approval number K193604. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptiva Celiac Disease IgA Reagent?

Aptiva Celiac Disease IgA Reagent is a medical device that received FDA 510(k) clearance on 2021-06-16. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K193604.

When was Aptiva Celiac Disease IgA Reagent approved by the FDA?

Aptiva Celiac Disease IgA Reagent received FDA 510(k) clearance on 2021-06-16, under approval number K193604.

What company makes Aptiva Celiac Disease IgA Reagent?

Aptiva Celiac Disease IgA Reagent is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for Aptiva Celiac Disease IgA Reagent?

The FDA product code for Aptiva Celiac Disease IgA Reagent is MVM.

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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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