FDA 510(k)

Atellica® IM High-Sensitivity Troponin I (TnIH)

K-Number: K241165 · 2024-07-25

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2024-07-25

Product CodeMMI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Atellica® IM High-Sensitivity Troponin I (TnIH) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-07-25 under 510(k) number K241165. 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 Atellica® IM High-Sensitivity Troponin I (TnIH)?

Atellica® IM High-Sensitivity Troponin I (TnIH) is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K241165.

When did Atellica® IM High-Sensitivity Troponin I (TnIH) receive FDA 510(k) clearance?

Atellica® IM High-Sensitivity Troponin I (TnIH) received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241165.

Who is the listed applicant for Atellica® IM High-Sensitivity Troponin I (TnIH)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH)?

The FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH) is MMI.

Other records listing Siemens Healthcare Diagnostics, 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.

K253528Atellica IM CA 19-9 II PMA P930027Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer PMA P010007KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS K261364Atellica CH Acetaminophen 2 (ACTM)PMA P930036KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS PMA P250026Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

View all 87 devices →

Related Devices (Code: MMI)

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.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.