Cleared Traditional

VIDAS D-DIMER (DD) ASSAY

K973819 · Biomerieux Vitek, Inc. · Hematology

Mar 1998

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K973819 is an FDA 510(k) clearance for the VIDAS D-DIMER (DD) ASSAY, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on March 10, 1998, 154 days after receiving the submission on October 7, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K973819 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1997
Decision Date	March 10, 1998
Days to Decision	154 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