K-number	K193490
Device name	SensiTox C. difficile Toxin Test
Applicant	First Light Diagnostics, Inc.
Product code	LLH
Device class	Class I
Decision date	Jul 8, 2021
Decision	Substantially Equivalent
Regulation	866.2660

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View the full FDA submission: accessdata.fda.gov

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SensiTox C. difficile Toxin Test

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