Olympus Ck-Mb Reagent

FDA 510(k) K070835 · Olympus Life & Material Science Europa GmbH (Irish

Substantially Equivalent

510(k) numberK070835

Submission

Device name
Olympus Ck-Mb Reagent
Applicant
Olympus Life & Material Science Europa GmbH (Irish
O'Callaghans Mills, Co. Clare, IE
Received
March 27, 2007
Decision date
June 4, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JHY – Colorimetric Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

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K143720Dimension Vista MMB AssayJHY · Traditional Siemens Healthcare Diagnostics09/18/2015SE
K130080Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional Medica Corporation05/13/2014SE
K140404Elecsys Ck-Mb Stat ImmunoassayJHY · Special Roche Diagnostics05/08/2014SE
K132571Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional Roche Diagnostics10/18/2013SE
K022757Spife CK Kit, Model 3332, 3333JHY · Traditional Helena Laboratories10/11/2002SE
K022654Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special Roche Diagnostics Corp.08/29/2002SE
K974421Elecsys Ck-Mb StatJHY · Traditional Boehringer Mannheim Corp.12/17/1997SE
K970343MMB MethodJHY · Traditional Dade Chemistry Systems, Inc.02/14/1997SE
K961412Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional Bayer Corp.06/18/1996SE
K951638Auraflex Ck-Mb 200TEST Pack, Calibrator PackJHY · Traditional Organon Teknika Corp.05/02/1995SE

More from Organon Teknika Corp.

510(k)DeviceDecision
K070708Olympus FT4-FREE Thyroxine, Olympus T4- Total Thyroxine, Model# OSR210102, OSR210104CEC · Traditional 08/21/2007SE
K070453Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…GHH · Traditional 06/11/2007SE

Questions and answers

When was Olympus Ck-Mb Reagent cleared by the FDA?

Olympus Ck-Mb Reagent (K070835) received a 510(k) decision of Substantially Equivalent on June 4, 2007, 69 days after the submission was received.

What is the product code of K070835?

The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.