Cleared Traditional

FIBROTEK FIB

K042919 · R2 Diagnostics, Inc. · Hematology
Nov 2004
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K042919 is an FDA 510(k) clearance for the FIBROTEK FIB, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on November 29, 2004, 38 days after receiving the submission on October 22, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K042919 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2004
Decision Date November 29, 2004
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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