The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista System Enzyme 6 Calibrator, Model Kc360.
| Device ID | K083579 |
| 510k Number | K083579 |
| Device Name: | DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-04 |
| Decision Date | 2009-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768026614 | K083579 | 000 |