K-number	K101185
Device name	NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
Applicant	Iris Molecular Diagnostics
Product code	OWM
Device class	Class II
Decision date	Sep 20, 2011
Decision	Substantially Equivalent
Regulation	866.6040

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View the full FDA submission: accessdata.fda.gov

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NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

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