K-number	K200811
Device name	cobas u 701 microscopy analyzer
Applicant	Roche Diagnostics
Product code	LKM
Device class	Class II
Decision date	Nov 6, 2020
Decision	Substantially Equivalent
Regulation	864.5200

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Source

View the full FDA submission: accessdata.fda.gov

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cobas u 701 microscopy analyzer

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