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FDA 510(k)

Aptiva APS IgA Reagent

K-Number: K243979 · 2026-02-06

ApplicantInova Diagnostics, Inc.
Decision Date2026-02-06
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva APS IgA Reagent is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-02-06 under approval number K243979. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptiva APS IgA Reagent?

Aptiva APS IgA Reagent is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K243979.

When was Aptiva APS IgA Reagent approved by the FDA?

Aptiva APS IgA Reagent received FDA 510(k) clearance on 2026-02-06, under approval number K243979.

What company makes Aptiva APS IgA Reagent?

Aptiva APS IgA Reagent is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for Aptiva APS IgA Reagent?

The FDA product code for Aptiva APS IgA Reagent is MSV.

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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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