The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Lithium Flex Reagent Cartridge.
| Device ID | K112142 |
| 510k Number | K112142 |
| Device Name: | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NDW |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-26 |
| Decision Date | 2011-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768035326 | K112142 | 000 |
| 00842768035319 | K112142 | 000 |