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 |