Cleared Traditional

STA? - Liatest? D-Di

K162227 · Diagnostica-Stago · Hematology

Dec 2016

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K162227 is an FDA 510(k) clearance for the STA? - Liatest? D-Di, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Diagnostica-Stago (Asnieres Sur Seine, FR). The FDA issued a Cleared decision on December 10, 2016, 124 days after receiving the submission on August 8, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K162227 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2016
Decision Date	December 10, 2016
Days to Decision	124 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