Sekisui Diagnostics P.E.I., Inc.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories4
Latest FDA decision2022-02-18
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K202644 | Acetaminophen | LDP | 2022-02-18 | View |
| 510(k) | K182702 | SEKURE Creatine Kinase Assay | CGS | 2019-04-17 | View |
| 510(k) | K180835 | SEKURE Acetaminophen L3K Assay | LDP | 2019-02-08 | View |
| 510(k) | K173206 | SEKURE HbA1c Assay | PDJ | 2018-07-12 | View |
| 510(k) | K163078 | DC-UIBC-CAL | JIT | 2016-12-08 | View |
No matching devices.