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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2025-01-03 under 510(k) 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. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K240984.

When did i-STAT hs-TnI cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

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

Who is the listed applicant for i-STAT hs-TnI cartridge with the i-STAT 1 System?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Abbott Point of Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemK253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemK234143i-STAT TBI Cartridge with the i-STAT Alinity SystemK230300i-STAT CG8+ cartridge with the i-STAT 1 SystemK230285i-STAT CG8+ cartridge with the i-STAT 1 System

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Related Devices (Code: MMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.K231974PATHFAST®hs-cTnI-IIPhc Corporation

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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