Cleared Traditional

STA- COAG CONTROL (N+ABN) PLUS

K120014 · Diagnostica Stago, Inc. · Hematology
Mar 2013
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K120014 is an FDA 510(k) clearance for the STA- COAG CONTROL (N+ABN) PLUS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on March 14, 2013, 441 days after receiving the submission on December 29, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K120014 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2011
Decision Date March 14, 2013
Days to Decision 441 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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