Olympus Creatine Kinase Reagent OSR6179/6279

FDA 510(k) K994189 · Olympus Diagnostica GmbH

Substantially Equivalent

510(k) numberK994189

Submission

Device name
Olympus Creatine Kinase Reagent OSR6179/6279
Applicant
Olympus Diagnostica GmbH
Melville, NY, US
Received
December 13, 1999
Decision date
January 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Arkray, Inc.

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K984145Olympus Myoglobin Immunoturbidmetric ReagentDDR · Traditional 12/23/1998SE
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Questions and answers

When was Olympus Creatine Kinase Reagent OSR6179/6279 cleared by the FDA?

Olympus Creatine Kinase Reagent OSR6179/6279 (K994189) received a 510(k) decision of Substantially Equivalent on January 20, 2000, 38 days after the submission was received.

What is the product code of K994189?

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.