Class Class II

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393)

K252393 2025-10-29 Traditional
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Description

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack by Ortho-Clinical Diagnostics, Inc., an FDA 510(k) cleared clinical chemistry device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252393
Clearance Date2025-10-29
Clearance TypeTraditional
Product CodeMMI
Regulation Number862.1215

Categories

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