Focus Diagnostics, Inc. · Class II · Cleared May 24, 2010
| K-number | K100148 |
| Device name | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
| Applicant | Focus Diagnostics, Inc. |
| Product code | OQW |
| Device class | Class II |
| Decision date | May 24, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 866.3332 |
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