Submission Details
| 510(k) Number | K090900 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 01, 2009 |
| Decision Date | June 01, 2009 |
| Days to Decision | 61 days |
| Submission Type | Abbreviated |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Abbreviated
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
Jun 2009
Decision
61d
Days
Class 2
Risk
About This 510(k) Submission
K090900 is an FDA 510(k) clearance for the ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on June 1, 2009, 61 days after receiving the submission on April 1, 2009. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.
Device Classification
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3200 |
Manufacturer
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