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FDA 510(k)

i-STAT hs-TnI cartridge with the i-STAT 1 System

K-Number: K240984 · 2025-01-03

ApplicantAbbott Point of Care, Inc.
Decision Date2025-01-03
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT hs-TnI cartridge with the i-STAT 1 System is a medical device manufactured by Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2025-01-03 under approval number K240984. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT hs-TnI cartridge with the i-STAT 1 System?

i-STAT hs-TnI cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2025-01-03. It is manufactured by Abbott Point of Care, Inc.. The 510(k) number is K240984.

When was i-STAT hs-TnI cartridge with the i-STAT 1 System approved by the FDA?

i-STAT hs-TnI cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2025-01-03, under approval number K240984.

What company makes i-STAT hs-TnI cartridge with the i-STAT 1 System?

i-STAT hs-TnI cartridge with the i-STAT 1 System is manufactured by Abbott Point of Care, Inc..

What is the FDA product code for i-STAT hs-TnI cartridge with the i-STAT 1 System?

The FDA product code for i-STAT hs-TnI cartridge with the i-STAT 1 System is MMI.

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Related Devices (Code: MMI)

K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5Roche Diagnostics K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K172787Access hsTnlBeckman Coulter, Inc. K172783Access hs TnlBeckman Coulter, Inc. K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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