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510(k) K230994

Alinity i STAT High Sensitivity Troponin-I by Abbott Laboratories Diagnostics Division — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
April 7, 2023
Clearance Type
Special
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

Other clearances by Abbott Laboratories Diagnostics Division

  • K240468 — Alkaline Phosphatase (October 16, 2024)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)
  • K191595 — ARCHITECT STAT High Sensitivity Troponin-I (September 13, 2019)

Other clearances for product code MMI

  • K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (October 29, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K242870 — Access hsTnI (June 16, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)
  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
  • K222881 — Access hsTnI (December 18, 2023)
  • K230648 — Access hsTnI (December 4, 2023)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)
  • K201441 — Elecsys Troponin T Gen 5 (September 21, 2021)