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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 the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) 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. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K213403.

When did Aptiva CTD Essential Reagent receive FDA 510(k) clearance?

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

Who is the listed applicant for Aptiva CTD Essential 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 CTD Essential Reagent?

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

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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Related Devices (Code: LLL)

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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