The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista; Ammonia Flex Reagent Cartridge (amm), Chemistry 3 Calibrator (chem 3 Cal).
| Device ID | K123677 |
| 510k Number | K123677 |
| Device Name: | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) |
| Classification | Enzymatic Method, Ammonia |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-30 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414948027 | K123677 | 000 |
| 00630414948102 | K123677 | 000 |