Cleared Traditional

LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

K083878 · R2 Diagnostics, Inc. · Hematology
Jun 2010
Decision
543d
Days
Class 1
Risk

About This 510(k) Submission

K083878 is an FDA 510(k) clearance for the LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA, a Reagent, Russel Viper Venom (Class I — General Controls, product code GIR), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on June 25, 2010, 543 days after receiving the submission on December 29, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number K083878 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2008
Decision Date June 25, 2010
Days to Decision 543 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIR — Reagent, Russel Viper Venom
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8950

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