Sekisui Diagnostics P.E.I. Inc.
FDA Regulatory Profile
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 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202644 | Acetaminophen | February 18, 2022 |
| K182702 | SEKURE Creatine Kinase Assay | April 17, 2019 |
| K180835 | SEKURE Acetaminophen L3K Assay | February 8, 2019 |
| K173206 | SEKURE HbA1c Assay | July 12, 2018 |
| K163078 | DC-UIBC-CAL | December 8, 2016 |
| K111915 | MAGNESIUM ASSAY | December 2, 2011 |