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Abbott Point of Care, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories8
Latest FDA decision2026-06-26
TypeNumberDevice NameCodeDateActions
510(k) K261039 i-STAT Crea cartridge with the i-STAT 1 SystemCGL2026-06-26 View
510(k) K253051 i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI2026-06-11 View
510(k) K244014 i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL2025-05-02 View
510(k) K240984 i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI2025-01-03 View
510(k) K230285 i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL2023-10-27 View
510(k) K230275 i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS2023-10-27 View
510(k) K230300 i-STAT CG8+ cartridge with the i-STAT 1 SystemJFP2023-10-27 View
510(k) K223857 i-STAT G3+ cartridge with the i-STAT 1 SystemCHL2023-09-15 View
510(k) K223755 i-STAT G cartridge with the i-STAT 1 SystemCGA2023-09-11 View
510(k) K223710 i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA2023-07-28 View
510(k) K210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2021-08-13 View
510(k) K200492 i-STAT CG4+ Cartridge with the i-STAT 1 SystemCHL2020-04-09 View
510(k) K183680 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJPI2020-02-28 View
510(k) K191360 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFP2020-02-14 View
510(k) K183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA2020-02-07 View
510(k) K183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS2020-02-07 View
510(k) K191298 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJFL2020-02-07 View
510(k) K163271 i-Stat Alinity System with i-Stat Glucose testCGA2017-04-10 View
510(k) K153357 i-STAT Alinity System with i-STAT Sodium testJGS2016-07-08 View
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