Sekisui Diagnostics P.E.I. Inc.
Sekisui Diagnostics P.E.I. Inc. appears in FDA public data with 2 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1078-2017, Class II) was initiated on November 29, 2016. Its most recent 510(k) clearance was granted on February 18, 2022.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1078-2017 | Class II | Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quant | November 29, 2016 |
| Z-1171-2016 | Class II | Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: | January 22, 2016 |