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510(k) K171274

ADVIA Centaur High-Sensitivity Troponin I (TNIH) by Siemens Healthcare Diagnostics, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2018
Date Received
May 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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Other clearances for product code MMI

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  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
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  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
  • K222881 — Access hsTnI (December 18, 2023)
  • K230648 — Access hsTnI (December 4, 2023)
  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)