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510(k) K252393

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack by Ortho-Clinical Diagnostics, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
July 31, 2025
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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  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K190520 — VITROS XT Chemistry Products GLU-Ca Slides (April 3, 2019)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K190326 — VITROS XT Chemistry Products UREA-CREA Slides (March 14, 2019)
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  • K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI (October 30, 2018)

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