K-number	DEN180014
Device name	WOUNDCHEK Bacterial Status
Applicant	Alere Scarborough, Inc.
Product code	QFA
Device class	Class II
Decision date	Dec 2, 2019
Decision	Not Substantially Equivalent
Regulation	866.3231

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Source

View the full FDA submission: accessdata.fda.gov

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WOUNDCHEK Bacterial Status

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