Creatine Kinase (CK)

FDA 510(k) K981218 · Abbott Laboratories

Substantially Equivalent

510(k) numberK981218

Submission

Device name
Creatine Kinase (CK)
Applicant
Abbott Laboratories
Irving, TX, US
Received
April 3, 1998
Decision date
May 1, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

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K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetCGS · Traditional Medtest DX08/11/2020SE
K182702SEKURE Creatine Kinase AssayCGS · Traditional Sekisui Diagnostics P.E.I., Inc.04/17/2019SE
K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS · Traditional Siemens Healthcare Diagnostics, Inc.09/07/2016SE
K123977Randox Liquid Ck-Mb, Randox Ck-Mb CalibratorCGS · Traditional Randox Laboratories, Ltd.11/21/2013SE
K112416CPK ReagentCGS · Traditional Vital Diagnostics (Manufacturing) Ptyltd11/09/2011SE
K083465Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…CGS · Special Siemens Healthcare Diagnostics02/27/2009SE
K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…CGS · Traditional Siemens Healthcare Diagnostics08/29/2008SE
K072548Creatine Kinase Liquid Reagent, Model C519-440CGS · Traditional Teco Diagnostics04/18/2008SE
K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerCGS · Traditional Horiba Abx06/12/2007SE
K051648Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional Arkray, Inc.01/31/2006SE

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Questions and answers

When was Creatine Kinase (CK) cleared by the FDA?

Creatine Kinase (CK) (K981218) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 28 days after the submission was received.

What is the product code of K981218?

The FDA product code is CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.