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FDA 510(k)

Alkaline Phosphatase

K-Number: K240468 · 2024-10-16

ApplicantAbbott Laboratories Diagnostics Division
Decision Date2024-10-16
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alkaline Phosphatase is a medical device manufactured by Abbott Laboratories Diagnostics Division. It received FDA 510(k) clearance on 2024-10-16 under approval number K240468. 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 Phosphatase?

Alkaline Phosphatase is a medical device that received FDA 510(k) clearance on 2024-10-16. It is manufactured by Abbott Laboratories Diagnostics Division. The 510(k) number is K240468.

When was Alkaline Phosphatase approved by the FDA?

Alkaline Phosphatase received FDA 510(k) clearance on 2024-10-16, under approval number K240468.

What company makes Alkaline Phosphatase?

Alkaline Phosphatase is manufactured by Abbott Laboratories Diagnostics Division.

What is the FDA product code for Alkaline Phosphatase?

The FDA product code for Alkaline Phosphatase 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.

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