K-number	K234091
Device name	Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
Applicant	Genalyte, Inc.
Product code	JLW
Device class	Class II
Decision date	Jul 22, 2024
Decision	Substantially Equivalent
Regulation	862.1690

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View the full FDA submission: accessdata.fda.gov

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Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

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