Cleared Traditional

SPECIALTY ASSAYED CONTROL-2

K100103 · Helena Laboratories · Hematology
Dec 2010
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K100103 is an FDA 510(k) clearance for the SPECIALTY ASSAYED CONTROL-2, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 15, 2010, 336 days after receiving the submission on January 13, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K100103 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2010
Decision Date December 15, 2010
Days to Decision 336 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

Similar Devices — GGC Control, Plasma, Abnormal

All 39
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
PLASMACON N, PLASMACON L-1, PLASMACON L-2
K062306 · R2 Diagnostics, Inc. · Mar 2007
STA - CONTROL LA 1+2
K061803 · Diagnostica Stago, Inc. · Jul 2006
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
K032804 · Precision Biologic · Nov 2003
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002