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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 the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) 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. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K223093.

When did Aptiva APS IgG Reagent; Aptiva APS IgM Reagent receive FDA 510(k) clearance?

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

Who is the listed applicant for Aptiva APS IgG Reagent; Aptiva APS IgM Reagent?

The FDA 510(k) record lists Inova Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Inova Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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