DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR— 510(k) K061296

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K061296 for DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR, Substantially Equivalent on 2006-06-13. Applicant: Diazyme Laboratories.

Clearance details

Applicant
Diazyme Laboratories
Product code
Code LPS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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