The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista System Enzyme 5 Calibrator, Model Kc350.
| Device ID | K083462 |
| 510k Number | K083462 |
| Device Name: | DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768026911 | K083462 | 000 |