Cleared Traditional

HemosIL ReadiPlasTin

K213426 · Instrumentation Laboratory CO · Hematology
Aug 2022
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K213426 is an FDA 510(k) clearance for the HemosIL ReadiPlasTin, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 16, 2022, 299 days after receiving the submission on October 21, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K213426 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2021
Decision Date August 16, 2022
Days to Decision 299 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750