Dimension Vista MMB Assay
FDA 510(k) K143720 · Siemens Healthcare Diagnostics
510(k) numberK143720
Submission
- Device name
- Dimension Vista MMB Assay
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- December 29, 2014
- Decision date
- September 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
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| 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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Questions and answers
When was Dimension Vista MMB Assay cleared by the FDA?
Dimension Vista MMB Assay (K143720) received a 510(k) decision of Substantially Equivalent on September 18, 2015, 263 days after the submission was received.
What is the product code of K143720?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.