K112142 is an FDA 510(k) clearance for the DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE. This device is classified as a Assay, Porphyrin, Spectrophotometry, Lithium (Class II - Special Controls, product code NDW).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 4, 2011, 101 days after receiving the submission on July 26, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K112142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2011 |
| Decision Date | November 04, 2011 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |