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FDA 510(k), K201778, i-STAT TBI Plasma cartridge with the i-STAT Alinity System
FDA 510(k), K201778, i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
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per
510(K) Number: K201778
Device Name: i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Manufacturer: Brian Ma
Device Classification Name: Brain Trauma Assessment Test
Regulation Number: QAT
Classification Product Code: 06/30/2020
Date Received: 01/08/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
Device Name: i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Manufacturer: Brian Ma
Device Classification Name: Brain Trauma Assessment Test
Regulation Number: QAT
Classification Product Code: 06/30/2020
Date Received: 01/08/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
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