Cleared Special

HemosIL Liquid Anti-Xa

K213464 · Instrumentation Laboratory CO · Hematology
Oct 2022
Decision
341d
Days
Class 2
Risk

About This 510(k) Submission

K213464 is an FDA 510(k) clearance for the HemosIL Liquid Anti-Xa, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on October 4, 2022, 341 days after receiving the submission on October 28, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K213464 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2021
Decision Date October 04, 2022
Days to Decision 341 days
Submission Type Special
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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