Creatinine2
K-Number: K210452 · 2022-03-22
ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-03-22
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Creatinine2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-03-22 under approval number K210452. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Creatinine2?
Creatinine2 is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K210452.
When was Creatinine2 approved by the FDA?
Creatinine2 received FDA 510(k) clearance on 2022-03-22, under approval number K210452.
What company makes Creatinine2?
Creatinine2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Creatinine2?
The FDA product code for Creatinine2 is CGX.
Other Devices by Abbott Ireland Diagnostics Division
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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.