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FDA 510(k) Applications Submitted by Susan Tibedo
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200492
02/28/2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
Abbott point of Care, Inc.
K140717
03/20/2014
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
SIEMENS HEALTHCARE DIAGNOSTICS
K191298
05/14/2019
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.
K191360
05/21/2019
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
K183678
12/28/2018
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott point of Care, Inc.
K183680
12/28/2018
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.
K183688
12/28/2018
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
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