The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Mmb Assay.
| Device ID | K143720 |
| 510k Number | K143720 |
| Device Name: | Dimension Vista MMB Assay |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | Siemens Healthcare Diagnostics 500 GBC Drive P.O. Box 6101 Newark, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons Siemens Healthcare Diagnostics 500 GBC Drive P.O. Box 6101 Newark, DE 19714 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015328 | K143720 | 000 |