FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
K Number: K253358
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
11
Review Days
80
Basic Information
- Device Name
- Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K Number
- K253358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- September 30, 2025
- Decision Date
- December 19, 2025
- Product Code
- DFH
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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