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FDA 510(k)

Aptiva Celiac Disease IgG Reagent

K-Number: K200230 · 2021-08-26

ApplicantInova Diagnostics, Inc.
Decision Date2021-08-26
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva Celiac Disease IgG Reagent is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-26 under approval number K200230. 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 IgG Reagent?

Aptiva Celiac Disease IgG Reagent is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K200230.

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

Aptiva Celiac Disease IgG Reagent received FDA 510(k) clearance on 2021-08-26, under approval number K200230.

What company makes Aptiva Celiac Disease IgG Reagent?

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

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

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

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Related Devices (Code: 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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