Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
FDA 510(k) clearance K252336 · decided 2026-04-24
Clearance details
- K-number
- K252336
- Device name
- Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
- Applicant
- Diazyme Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-28
- Decision date
- 2026-04-24
- Days to decision
- 270 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.