Cleared Traditional

PLASMACON N, PLASMACON L-1, PLASMACON L-2

K062306 · R2 Diagnostics, Inc. · Hematology
Mar 2007
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K062306 is an FDA 510(k) clearance for the PLASMACON N, PLASMACON L-1, PLASMACON L-2, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on March 16, 2007, 220 days after receiving the submission on August 8, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K062306 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2006
Decision Date March 16, 2007
Days to Decision 220 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425