FDA 510(k), K191298, i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA 510(k), K191298, i-STAT CHEM8+ cartridge with the i-STAT 1 System

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510(K) Number: K191298
Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer: Susan Tibedo
Device Classification Name: Ph Rate Measurement, Carbon-Dioxide
Regulation Number: JFL
Classification Product Code: 05/14/2019
Date Received: 02/07/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry

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