K083878

Substantially Equivalent

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

Applicant: R2 Diagnostics, Inc.
Product code: GIR
Advisory panel: Hematology
Date received: 2008-12-29
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

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