Submission Details
| 510(k) Number | K112142 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
Nov 2011
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K112142 is an FDA 510(k) clearance for the DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE, 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 review panel. Regulated under 21 CFR 862.3560.
Device Classification
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3560 |
Manufacturer
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