Cleared Traditional

NOFACT VIII

K102851 · R2 Diagnostics, Inc. · Hematology
Dec 2011
Decision
446d
Days
Class 2
Risk

About This 510(k) Submission

K102851 is an FDA 510(k) clearance for the NOFACT VIII, 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, 446 days after receiving the submission on September 29, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K102851 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2010
Decision Date December 19, 2011
Days to Decision 446 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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