Urea Nitrogen2
K-Number: K203771 · 2022-05-31
ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-05-31
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Urea Nitrogen2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-05-31 under approval 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. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K203771.
When was Urea Nitrogen2 approved by the FDA?
Urea Nitrogen2 received FDA 510(k) clearance on 2022-05-31, under approval number K203771.
What company makes Urea Nitrogen2?
Urea Nitrogen2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Urea Nitrogen2?
The FDA product code for Urea Nitrogen2 is CDQ.
Other Devices by Abbott Ireland Diagnostics Division
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.