Cleared Special

HemosIL Silica Clotting Time

K160445 · Instrumentation Laboratory CO · Hematology
Mar 2016
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K160445 is an FDA 510(k) clearance for the HemosIL Silica Clotting Time, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 16, 2016, 28 days after receiving the submission on February 17, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K160445 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2016
Decision Date March 16, 2016
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

Similar Devices — GFO Activated Partial Thromboplastin

All 51
HemosIL Silica Clotting Time
K253957 · Instrumentation Laboratory (IL) Co. · Jan 2026
Cryocheck Hex LA
K193556 · Precision Biologic · Oct 2020
STA-CEPHASCREEN KIT
K053111 · Diagnostica Stago, Inc. · May 2006
HEMOSIL SYNTHASIL
K060688 · Instrumentation Laboratory CO · Apr 2006
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · Vital Scientific N.V. · Nov 2002