FDA 510(k) Applications Submitted by SEKISUI DIAGNOSTICS P.E.I. INC.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K182702 | 09/27/2018 | SEKURE Creatine Kinase Assay | SEKISUI DIAGNOSTICS P.E.I. INC. |
| K202644 | 09/11/2020 | Acetaminophen | Sekisui Diagnostics P.E.I. INC. |
| K163078 | 11/03/2016 | DC-UIBC-CAL | SEKISUI DIAGNOSTICS P.E.I. INC. |
| K111915 | 07/06/2011 | MAGNESIUM ASSAY | SEKISUI DIAGNOSTICS P.E.I. INC. |
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