Cleared Special

HemosIL D-Dimer HS

K160885 · Instrumentation Laboratory CO · Hematology

Oct 2016

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K160885 is an FDA 510(k) clearance for the HemosIL D-Dimer HS, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 27, 2016, 210 days after receiving the submission on March 31, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K160885 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2016
Decision Date	October 27, 2016
Days to Decision	210 days
Submission Type	Special
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