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FDA 510(k)

Aptiva CTD Essential Reagent

K-Number: K213403 · 2023-09-29

ApplicantInova Diagnostics, Inc.
Decision Date2023-09-29
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Aptiva CTD Essential Reagent is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-09-29 under approval number K213403. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aptiva CTD Essential Reagent?

Aptiva CTD Essential Reagent is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K213403.

When was Aptiva CTD Essential Reagent approved by the FDA?

Aptiva CTD Essential Reagent received FDA 510(k) clearance on 2023-09-29, under approval number K213403.

What company makes Aptiva CTD Essential Reagent?

Aptiva CTD Essential Reagent is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for Aptiva CTD Essential Reagent?

The FDA product code for Aptiva CTD Essential Reagent is LLL.

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Related Devices (Code: LLL)

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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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