Cleared Traditional

STA LIATEST D-DI

K141144 · Diagnostica-Stago · Hematology

Sep 2014

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K141144 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 (Rome, IT). The FDA issued a Cleared decision on September 3, 2014, 124 days after receiving the submission on May 2, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K141144 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2014
Decision Date	September 03, 2014
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