Cleared Special

HemosIL von Willebrand Factor Antigen

K200033 · Instrumentation Laboratory CO · Hematology
Aug 2020
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K200033 is an FDA 510(k) clearance for the HemosIL von Willebrand Factor Antigen, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 19, 2020, 225 days after receiving the submission on January 7, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K200033 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2020
Decision Date August 19, 2020
Days to Decision 225 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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