Cleared Traditional

POOL NORM

K142132 · Diagnostics Stago S.A.S. · Hematology

Dec 2014

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K142132 is an FDA 510(k) clearance for the POOL NORM, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Diagnostics Stago S.A.S. (Gennevilliers, FR). The FDA issued a Cleared decision on December 12, 2014, 130 days after receiving the submission on August 4, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K142132 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2014
Decision Date	December 12, 2014
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF