Cleared Traditional

HEMOSIL D-DIMER

K073042 · Instrumentation Laboratory · Hematology

Jul 2008

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K073042 is an FDA 510(k) clearance for the HEMOSIL D-DIMER, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Instrumentation Laboratory (Lexington, US). The FDA issued a Cleared decision on July 31, 2008, 276 days after receiving the submission on October 29, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K073042 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2007
Decision Date	July 31, 2008
Days to Decision	276 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