Cleared Traditional

FIBRINOGEN CALIBRATOR KIT

K072304 · Dade Behring, Inc. · Hematology
Sep 2007
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K072304 is an FDA 510(k) clearance for the FIBRINOGEN CALIBRATOR KIT, a Fibrinogen Standard (Class II — Special Controls, product code GFX), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 19, 2007, 33 days after receiving the submission on August 17, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K072304 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2007
Decision Date September 19, 2007
Days to Decision 33 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFX — Fibrinogen Standard
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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