Epitope Diagnostics, Inc.
FDA Regulatory Profile
Epitope Diagnostics, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0426-2021, Class II) was initiated on October 1, 2020. Its most recent 510(k) clearance was granted on October 3, 2005.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0426-2021 | Class II | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for q | October 1, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | October 3, 2005 |