The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Chemistry Iii Calibratory.
| Device ID | K123321 |
| 510k Number | K123321 |
| Device Name: | DIMENSION CHEMISTRY III CALIBRATORY |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-26 |
| Decision Date | 2013-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948034 | K123321 | 000 |
| 00630414597379 | K123321 | 000 |