510(k) K191167
- Device
- Fungitell STAT
- Applicant
- Associates Of Cape Cod, Inc
- 510(k) number
- K191167
- Product code
- NQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-17
- Date received
- 2019-05-01
- Regulation
- 866.3050
- Classification name
- Antigen, Invasive Fungal Pathogens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alison Skinner
- Address
- 124 Bernard E. Saint Jean Dr. East Falmouth MA US 02536 02536
FDA Registration Numbers#
- 1219145
Source Documents#
Other 510(k) Records For Product Code NQZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN040003 | GLUCATELL | Associates of Cape Cod, Inc. | 2004-05-21 |
Legacy Summary#
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FDA Review#
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