K023407

Substantially Equivalent

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

Applicant: Elan Diagnostics
Product code: CGX
Advisory panel: Clinical Chemistry
Date received: 2002-10-10
Decision date: 2003-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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