The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista System Trf Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, And Dimension Vista.
| Device ID | K081299 |
| 510k Number | K081299 |
| Device Name: | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | DDG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-08 |
| Decision Date | 2008-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006258 | K081299 | 000 |
| 00842768024498 | K081299 | 000 |