K081063 is an FDA 510(k) clearance for the SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS. This device is classified as a Susceptibility Test Plate, Antifungal (Class II - Special Controls, product code NGZ).
Submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 6, 2009, 326 days after receiving the submission on April 14, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format..
| 510(k) Number | K081063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2008 |
| Decision Date | March 06, 2009 |
| Days to Decision | 326 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | NGZ — Susceptibility Test Plate, Antifungal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format. |