The following data is part of a De Novo classification by Maine Molecular Quality Controls, Inc. with the FDA for Introl Cf Panel I Control.
| DeNovo ID | DEN060007 |
| Device Name: | INTROL CF PANEL I CONTROL |
| Classification | Quality Control Material, Genetics, Dna |
| Applicant | MAINE MOLECULAR QUALITY CONTROLS, INC. 10 Southgate Road Scarborough, ME 04074 |
| Contact | Joan Gordon |
| Product Code | NZB |
| CFR Regulation Number | 866.5910 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K060070 |
| Review Advisory Board | Pathology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2006-08-14 |
| Decision Date | 2006-10-12 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |