The following data is part of a De Novo classification by Associates Of Cape Cod, Inc. with the FDA for Glucatell.
| DeNovo ID | DEN040003 |
| Device Name: | GLUCATELL |
| Classification | Antigen, Invasive Fungal Pathogens |
| Applicant | ASSOCIATES OF CAPE COD, INC. 1738 Tamberwood Echo Woodbury, MN 55125 |
| Contact | Stacy Suberg |
| Product Code | NQZ |
| CFR Regulation Number | 866.3050 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K032373 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2004-03-22 |
| Decision Date | 2004-05-21 |
| Reclassification Order: | Reclassification Order |