Cleared Traditional

VIDAS D-DIMER EXCLUSION II (DEX2)

K112818 · bioMerieux, Inc. · Hematology

Jul 2012

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K112818 is an FDA 510(k) clearance for the VIDAS D-DIMER EXCLUSION II (DEX2), a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 31, 2012, 307 days after receiving the submission on September 28, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K112818 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2011
Decision Date	July 31, 2012
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

Device Classification

Product Code	DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7320