K100263

Substantially Equivalent

ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS

Applicant: Seppim S.A.S.
Product code: CEO
Advisory panel: Clinical Chemistry
Date received: 2010-01-28
Decision date: 2011-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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