Tm Bioscience Corporation · Class II · Cleared May 9, 2005
| K-number | DEN050004 |
| Device name | TAG-IT CYSTIC FIBROSIS KIT |
| Applicant | Tm Bioscience Corporation |
| Product code | NUA |
| Device class | Class II |
| Decision date | May 9, 2005 |
| Decision | Not Substantially Equivalent |
| Regulation | 866.5900 |
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