SEKURE Creatine Kinase Assay

FDA 510(k) K182702 · Sekisui Diagnostics P.E.I., Inc.

Substantially Equivalent

510(k) numberK182702

Submission

Device name
SEKURE Creatine Kinase Assay
Applicant
Sekisui Diagnostics P.E.I., Inc.
Charlottetown,, CA
Received
September 27, 2018
Decision date
April 17, 2019
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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K043202Olympus Creatine Kinase Reagent OSR6179/OSR6279CGS · Traditional Olympus America, Inc.12/23/2004SE

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Questions and answers

When was SEKURE Creatine Kinase Assay cleared by the FDA?

SEKURE Creatine Kinase Assay (K182702) received a 510(k) decision of Substantially Equivalent on April 17, 2019, 202 days after the submission was received.

What is the product code of K182702?

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.