Elecsys Ck-Mb Stat Immunoassay
FDA 510(k) K140404 · Roche Diagnostics
510(k) numberK140404
Submission
- Device name
- Elecsys Ck-Mb Stat Immunoassay
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- February 18, 2014
- Decision date
- May 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143720 | Dimension Vista MMB AssayJHY · Traditional | Siemens Healthcare Diagnostics | 09/18/2015SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | Medica Corporation | 05/13/2014SE |
| K132571 | Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional | Roche Diagnostics | 10/18/2013SE |
| K070835 | Olympus Ck-Mb ReagentJHY · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/04/2007SE |
| K022757 | Spife CK Kit, Model 3332, 3333JHY · Traditional | Helena Laboratories | 10/11/2002SE |
| K022654 | Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special | Roche Diagnostics Corp. | 08/29/2002SE |
| K974421 | Elecsys Ck-Mb StatJHY · Traditional | Boehringer Mannheim Corp. | 12/17/1997SE |
| K970343 | MMB MethodJHY · Traditional | Dade Chemistry Systems, Inc. | 02/14/1997SE |
| K961412 | Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional | Bayer Corp. | 06/18/1996SE |
| K951638 | Auraflex Ck-Mb 200TEST Pack, Calibrator PackJHY · Traditional | Organon Teknika Corp. | 05/02/1995SE |
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| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
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Questions and answers
When was Elecsys Ck-Mb Stat Immunoassay cleared by the FDA?
Elecsys Ck-Mb Stat Immunoassay (K140404) received a 510(k) decision of Substantially Equivalent on May 8, 2014, 79 days after the submission was received.
What is the product code of K140404?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.