The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Chemistry 1 Calibrator (chem 1 Cal), Dimension Vista Magnesium Flex Reagent Cartridge (mg).
| Device ID | K140790 |
| 510k Number | K140790 |
| Device Name: | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex Reagent Cartridge (MG) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19714 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19714 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2015-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948508 | K140790 | 000 |
| 00842768015694 | K140790 | 000 |