Associates of Cape Cod, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1774-2022 | Class II | Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 | August 17, 2022 |
| Z-1329-2019 | Class II | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorim | December 19, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191167 | Fungitell STAT | July 17, 2019 |
| DEN040003 | GLUCATELL | May 21, 2004 |