Cleared Special

HEMOSIL LIQUID ANTITHROMBIN

K062431 · Instrumentation Laboratory CO · Hematology
Sep 2006
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K062431 is an FDA 510(k) clearance for the HEMOSIL LIQUID ANTITHROMBIN, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 1, 2006, 11 days after receiving the submission on August 21, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K062431 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2006
Decision Date September 01, 2006
Days to Decision 11 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

Similar Devices — JBQ Antithrombin Iii Quantitation

All 55
INNOVANCE Antithrombin
K242952 · Siemens Healthcare Diagnostic Products GmbH · Mar 2025
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · Siemens Healthcare Diagnostics · May 2009
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
K043007 · Hyphen Biomed · Nov 2005
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · Instrumentation Laboratory CO · Jan 2004
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
K023991 · Precision Biologic · Apr 2003