LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA— 510(k) K083878

Name: FDA 510(k) clearance K083878
Creator: U.S. Food and Drug Administration
Published: 2010-06-25

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K083878 for LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA, Substantially Equivalent on 2010-06-25. Applicant: R2 Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 2008-12-29
Decision date: 2010-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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