Instrumentation Laboratory CO · Class II · Cleared Oct 9, 2009
| K-number | K090563 |
| Device name | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) |
| Applicant | Instrumentation Laboratory CO |
| Product code | GGN |
| Device class | Class II |
| Decision date | Oct 9, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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