510(k) DEN040003
- Device
- GLUCATELL
- Applicant
- Associates of Cape Cod, Inc.
- 510(k) number
- DEN040003
- Product code
- NQZ
- Decision
- Unknown (DENG)
- Decision date
- 2004-05-21
- Date received
- 2004-03-22
- Regulation
- 866.3050
- Classification name
- Antigen, Invasive Fungal Pathogens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- STACY SUBERG
- Address
- 1738 Tamberwood Echo Woodbury MN US 55125 55125
FDA Registration Numbers#
- 1219145
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NQZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191167 | Fungitell STAT | Associates of Cape Cod, Inc. | 2019-07-17 |