K252336
- 510(k) number
- K252336
- Device name
- Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
- Applicant
- Diazyme Laboratories, Inc. CA · US
- Decision date
- 2026-04-24
- Date received
- 2025-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252336
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.