K090346 is an FDA 510(k) clearance for the ADVIA 2120/2120I BODY FLUIDS. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on July 28, 2010, 532 days after receiving the submission on February 11, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K090346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2009 |
| Decision Date | July 28, 2010 |
| Days to Decision | 532 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |