Cleared Special

HEMOSIL LIQUID ANTITHROMBIN XL

K033775 · Instrumentation Laboratory CO · Hematology
Jan 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K033775 is an FDA 510(k) clearance for the HEMOSIL LIQUID ANTITHROMBIN XL, 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 January 2, 2004, 30 days after receiving the submission on December 3, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K033775 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2003
Decision Date January 02, 2004
Days to Decision 30 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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