Cleared Special

Alkaline Phosphatase

K240468 · Abbott Laboratories Diagnostics Division · Chemistry
Oct 2024
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K240468 is an FDA 510(k) clearance for the Alkaline Phosphatase, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Abbott Laboratories Diagnostics Division (Irving, US). The FDA issued a Cleared decision on October 16, 2024, 239 days after receiving the submission on February 20, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K240468 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date October 16, 2024
Days to Decision 239 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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