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FDA 510(k) Applications Submitted by ABBOTT POINT OF CARE INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K223710
12/12/2022
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.
K103195
10/29/2010
I-STAT 1 WIRELESS ANALYZER
ABBOTT POINT OF CARE INC.
K210958
03/31/2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.
K133002
09/24/2013
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
ABBOTT POINT OF CARE INC.
K153357
11/20/2015
i-STAT Alinity System with i-STAT Sodium test
ABBOTT POINT OF CARE INC.
K223755
12/15/2022
i-STAT G cartridge with the i-STAT 1 System
Abbott Point of Care Inc.
K191298
05/14/2019
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.
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