DNA Genotek, Inc. · Class II · Cleared Dec 2, 2011
| K-number | K110701 |
| Device name | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 |
| Applicant | DNA Genotek, Inc. |
| Product code | OYJ |
| Device class | Class II |
| Decision date | Dec 2, 2011 |
| Decision | Substantially Equivalent |
| Regulation | 862.1675 |
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