Alkaline Phosphatase2
K-Number: K223317 · 2023-07-21
ApplicantAbbott Ireland Diagnostics Division
Decision Date2023-07-21
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Alkaline Phosphatase2 is a medical device manufactured by Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2023-07-21 under approval number K223317. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alkaline Phosphatase2?
Alkaline Phosphatase2 is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Abbott Ireland Diagnostics Division. The 510(k) number is K223317.
When was Alkaline Phosphatase2 approved by the FDA?
Alkaline Phosphatase2 received FDA 510(k) clearance on 2023-07-21, under approval number K223317.
What company makes Alkaline Phosphatase2?
Alkaline Phosphatase2 is manufactured by Abbott Ireland Diagnostics Division.
What is the FDA product code for Alkaline Phosphatase2?
The FDA product code for Alkaline Phosphatase2 is CJE.
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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.