K-number	K212648
Device name	VITROS Immunodiagnostic Products CK-MB Reagent Pack
Applicant	Ortho Clinical Diagnostics
Product code	JHX
Device class	Class II
Decision date	Jan 28, 2022
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products CK-MB Reagent Pack

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