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FDA 510(k)

Urea Nitrogen2

K-Number: K203771 · 2022-05-31

Decision Date2022-05-31
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Urea Nitrogen2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K203771. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Urea Nitrogen2?

Urea Nitrogen2 is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203771.

When did Urea Nitrogen2 receive FDA 510(k) clearance?

Urea Nitrogen2 received FDA 510(k) clearance on 2022-05-31, under 510(k) number K203771.

Who is the listed applicant for Urea Nitrogen2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Urea Nitrogen2?

The FDA product code for Urea Nitrogen2 is CDQ.

Other records listing Abbott Ireland Diagnostics Division 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.