Cleared Traditional

HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS

K090209 · Instrumentation Laboratory CO · Hematology
Jun 2009
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K090209 is an FDA 510(k) clearance for the HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on June 2, 2009, 125 days after receiving the submission on January 28, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K090209 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2009
Decision Date June 02, 2009
Days to Decision 125 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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