VIDAS D-DIMER EXCLUSION II (DEX2)— 510(k) K112818

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code DAP

Device class

Class 2

Regulation

21 CFR 864.7320

Advisory panel

Hematology

Date received

2011-09-28

Decision date

2012-07-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

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• Z-2232-2014 — VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.Class II·Terminated·BioMerieux SA·20130417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112818.