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510(k) K242870

Access hsTnI by Beckman Coulter, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2025
Date Received
September 23, 2024
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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  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)
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