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FDA 510(k)

HemosIL ReadiPlasTin

K-Number: K213426 · 2022-08-16

ApplicantInstrumentation Laboratory CO
Decision Date2022-08-16
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HemosIL ReadiPlasTin is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2022-08-16 under approval number K213426. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemosIL ReadiPlasTin?

HemosIL ReadiPlasTin is a medical device that received FDA 510(k) clearance on 2022-08-16. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K213426.

When was HemosIL ReadiPlasTin approved by the FDA?

HemosIL ReadiPlasTin received FDA 510(k) clearance on 2022-08-16, under approval number K213426.

What company makes HemosIL ReadiPlasTin?

HemosIL ReadiPlasTin is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for HemosIL ReadiPlasTin?

The FDA product code for HemosIL ReadiPlasTin is GJS.

Other Devices by Instrumentation Laboratory CO

K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160885HemosIL D-Dimer HS K161818GEM Premier 3000

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Related Devices (Code: GJS)

K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics K170960CoaguChek Vantus SystemRoche Diagnostics K180684CoaguChek XS Plus SystemRoche Diagnostics K180693CoaguChek XS Pro SystemRoche Diagnostics K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. K180780microINR SystemIline Microsystems, S.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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