Cleared Traditional

NOFACT IX

K102908 · R2 Diagnostics, Inc. · Hematology
Dec 2011
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K102908 is an FDA 510(k) clearance for the NOFACT IX, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on December 19, 2011, 444 days after receiving the submission on October 1, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K102908 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2010
Decision Date December 19, 2011
Days to Decision 444 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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