Alkaline Phosphatase

FDA 510(k) K240468 · Abbott Laboratories Diagnostics Division

Substantially Equivalent

510(k) numberK240468

Submission

Device name
Alkaline Phosphatase
Applicant
Abbott Laboratories Diagnostics Division
Irving, TX, US
Received
February 20, 2024
Decision date
October 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Specialty
Clinical Chemistry

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K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…CJE · Traditional Lite-On Technology Corp. H.S.P.B.01/25/2018SE
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K162275Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional Randox Laboratories Limited04/21/2017SE
K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentCJE · Traditional Alfa Wassermann Diagnostic Technologies, LLC08/15/2013SE
K130141S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional Hitachi Chemical Diagnostics, Inc.03/22/2013SE
K113436Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L ReagentCJE · Traditional Alfa Wassermann07/12/2012SE
K113269Elittech Clinical Systems Alp Ifcc SLCJE · Traditional Elitechgroup12/29/2011SE

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Questions and answers

When was Alkaline Phosphatase cleared by the FDA?

Alkaline Phosphatase (K240468) received a 510(k) decision of Substantially Equivalent on October 16, 2024, 239 days after the submission was received.

What is the product code of K240468?

The FDA product code is CJE – Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.