Sekisui Diagnostics P.E.I., Inc.
Medical device manufacturer in Charlottetown, CA.
6510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K202644 | AcetaminophenLDP · Traditional | 02/18/2022SE |
| K182702 | SEKURE Creatine Kinase AssayCGS · Traditional | 04/17/2019SE |
| K180835 | SEKURE Acetaminophen L3K AssayLDP · Traditional | 02/08/2019SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | 07/12/2018SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | 12/08/2016SE |
| K111915 | Magnesium AssayJGJ · Traditional | 12/02/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1078-2017 Class II | Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN…Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an… | 11/29/2016Terminated |
| Z-1171-2016 Class II | Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic…Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under… | 01/22/2016Terminated |