K-number	K200236
Device name	VITROS BRAHMS PCT Reagent Pack and Calibrators
Applicant	Ortho Clinical Diagnostics
Product code	PMT
Device class	Class II
Decision date	Feb 25, 2020
Decision	Substantially Equivalent
Regulation	866.3215

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS BRAHMS PCT Reagent Pack and Calibrators

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