K162281

Substantially Equivalent

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

Applicant: Sebia
Product code: LCP
Advisory panel: Hematology
Date received: 2016-08-15
Decision date: 2017-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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