DeviceClearance

Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay— 510(k) K181438

Substantially Equivalent

Diazyme 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..

Clearance details

Applicant
Diazyme Laboratories, Inc.
Product code
Code DFH
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Poway, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.