DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT— 510(k) K110188

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K110188 for DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT, Substantially Equivalent on 2011-05-17. Applicant: Diazyme Laboratories.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code LCP
Advisory panel: Hematology
Date received: 2011-01-24
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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