Cleared Traditional

LUPOTEK KCT

K090105 · R2 Diagnostics, Inc. · Hematology
Dec 2010
Decision
714d
Days
Class 2
Risk

About This 510(k) Submission

K090105 is an FDA 510(k) clearance for the LUPOTEK KCT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on December 30, 2010, 714 days after receiving the submission on January 15, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K090105 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2009
Decision Date December 30, 2010
Days to Decision 714 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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