Cleared Special

HemosIL Factor XII Deficient Plasma

K180486 · Instrumentation Laboratory CO · Hematology
Mar 2018
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K180486 is an FDA 510(k) clearance for the HemosIL Factor XII Deficient Plasma, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 22, 2018, 27 days after receiving the submission on February 23, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K180486 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2018
Decision Date March 22, 2018
Days to Decision 27 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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