K132399

Substantially Equivalent

ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL

Applicant: Elitechgroup
Product code: JFY
Advisory panel: Clinical Chemistry
Date received: 2013-08-01
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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