Fungitell STAT
Antigen, Invasive Fungal Pathogens
Associates Of Cape Cod, Inc
The following data is part of a premarket notification filed by Associates Of Cape Cod, Inc with the FDA for Fungitell Stat.
Pre-market Notification Details
| Device ID | K191167 |
| 510k Number | K191167 |
| Device Name: | Fungitell STAT |
| Classification | Antigen, Invasive Fungal Pathogens |
| Applicant | Associates Of Cape Cod, Inc 124 Bernard East Saint Jean Drive East Falmouth, MA 02536 |
| Contact | Alison Skinner |
| Correspondent | Alison Skinner Associates Of Cape Cod, Inc 124 Bernard East Saint Jean Drive East Falmouth, MA 02536 |
| Product Code | NQZ |
| CFR Regulation Number | 866.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-07-17 |
Trademark Results [Fungitell STAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FUNGITELL STAT 88123455 not registered Live/Pending |
Associates of Cape Cod, Inc. 2018-09-19 |
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