Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay— 510(k) K181438
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K181438 for Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay, Substantially Equivalent on 2018-06-26. 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
- Special
- Location
- Poway, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.