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Abbott Point of Care, Inc. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
i-STAT Crea cartridge with the i-STAT 1 System510(k)Jun 26, 2026Clinical Chemistry
i-STAT hs-TnI cartridge with the i-STAT Alinity System510(k)Jun 11, 2026Clinical Chemistry
i-STAT CG4+ cartridge with the i-STAT 1 System510(k)May 2, 2025Clinical Chemistry
i-STAT hs-TnI cartridge with the i-STAT 1 System510(k)Jan 3, 2025Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System510(k)Oct 27, 2023Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System510(k)Oct 27, 2023Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System510(k)Oct 27, 2023Clinical Chemistry
i-STAT G3+ cartridge with the i-STAT 1 System510(k)Sep 15, 2023Clinical Chemistry
i-STAT G cartridge with the i-STAT 1 System510(k)Sep 11, 2023Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System510(k)Jul 28, 2023Clinical Chemistry
i-STAT CHEM8+ cartridge with the i-STAT 1 System510(k)Aug 13, 2021Clinical Chemistry

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