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FDA 510(k)

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

K-Number: K223093 · 2024-12-17

ApplicantInova Diagnostics, Inc.
Decision Date2024-12-17
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K223093. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptiva APS IgG Reagent; Aptiva APS IgM Reagent?

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K223093.

When was Aptiva APS IgG Reagent; Aptiva APS IgM Reagent approved by the FDA?

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent received FDA 510(k) clearance on 2024-12-17, under approval number K223093.

What company makes Aptiva APS IgG Reagent; Aptiva APS IgM Reagent?

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for Aptiva APS IgG Reagent; Aptiva APS IgM Reagent?

The FDA product code for Aptiva APS IgG Reagent; Aptiva APS IgM Reagent is MID.

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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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