K093939 is an FDA 510(k) clearance for the ADVIA CHEMISTRY SALICYLATE REAGENT. This device is classified as a Colorimetry, Salicylate (Class II - Special Controls, product code DKJ).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on May 19, 2010, 148 days after receiving the submission on December 22, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K093939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2009 |
| Decision Date | May 19, 2010 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |