FDA 510(k) Applications Submitted by Sekisui Diagnostics PEI Inc.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K180835 | 03/30/2018 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics PEI Inc. |
| K173206 | 10/02/2017 | SEKURE HbA1c Assay | Sekisui Diagnostics PEI Inc. |
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