Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay— 510(k) K211648
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K211648 for Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Substantially Equivalent on 2022-09-08. Applicant: Diazyme Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diazyme Laboratories, Inc.
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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