Biointellisense Inc.
Biointellisense Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2616-2024, Class II) was initiated on July 19, 2024. Its most recent 510(k) clearance was granted on September 26, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2616-2024 | Class II | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring | July 19, 2024 |