K-number	K203527
Device name	Immunalysis Tapentadol Urine HEIA
Applicant	Lmmunalysis Corporation
Product code	DJG
Device class	Class II
Decision date	May 9, 2022
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis Tapentadol Urine HEIA

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