I-Sens, Inc. · Class II · Cleared Sep 5, 2012
| K-number | K121654 |
| Device name | AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION |
| Applicant | I-Sens, Inc. |
| Product code | CGA |
| Device class | Class II |
| Decision date | Sep 5, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
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