K-number	K201956
Device name	Zeus IFA ANA HEp-2 Test System, Zeus dIFine
Applicant	Zeus Scientific, Inc.
Product code	DHN
Device class	Class II
Decision date	Apr 29, 2022
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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Zeus IFA ANA HEp-2 Test System, Zeus dIFine

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