Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
Device Facts
| Record ID | K252336 |
|---|---|
| Device Name | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay |
| Applicant | Diazyme Laboratories, Inc. |
| Decision Date | Apr 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |