K-number	K191350
Device name	ACTIVE® Free Testosterone RIA
Applicant	Immunotech S.R.O.
Product code	CDZ
Device class	Class I
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	862.1680

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Source

View the full FDA submission: accessdata.fda.gov

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ACTIVE® Free Testosterone RIA

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