Cleared Traditional

Alkaline Phosphatase2

K223317 · Abbott Ireland Diagnostics Division · Chemistry
Jul 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K223317 is an FDA 510(k) clearance for the Alkaline Phosphatase2, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Abbott Ireland Diagnostics Division (Longsford, IE). The FDA issued a Cleared decision on July 21, 2023, 266 days after receiving the submission on October 28, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K223317 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2022
Decision Date July 21, 2023
Days to Decision 266 days
Submission Type Traditional
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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