Cleared Special

HEMOSIL ANTITHROMBIN

K070301 · Instrumentation Laboratory CO · Hematology
Feb 2007
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K070301 is an FDA 510(k) clearance for the HEMOSIL 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 February 23, 2007, 23 days after receiving the submission on January 31, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K070301 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2007
Decision Date February 23, 2007
Days to Decision 23 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

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