Cleared Special

HemosIL D-Dimer HS

K151534 · Instrumentation Laboratory CO · Hematology

Jul 2015

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K151534 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 July 6, 2015, 28 days after receiving the submission on June 8, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K151534 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2015
Decision Date	July 06, 2015
Days to Decision	28 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