Cleared Special

HemosIL D-Dimer HS 500

K172903 · Instrumentation Laboratory CO · Hematology

Nov 2017

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K172903 is an FDA 510(k) clearance for the HemosIL D-Dimer HS 500, 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 November 22, 2017, 61 days after receiving the submission on September 22, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K172903 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2017
Decision Date	November 22, 2017
Days to Decision	61 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