Submission Details
| 510(k) Number | K093939 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ADVIA CHEMISTRY SALICYLATE REAGENT
May 2010
Decision
148d
Days
Class 2
Risk
About This 510(k) Submission
K093939 is an FDA 510(k) clearance for the ADVIA CHEMISTRY SALICYLATE REAGENT, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Siemens Healthcare Diagnostics (New York, 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 review panel. Regulated under 21 CFR 862.3830.
Device Classification
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3830 |
Manufacturer
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