K-number	K980376
Device name	THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Applicant	Bayer Corp.
Product code	LTJ
Device class	Class II
Decision date	Apr 23, 1998
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Everything you need for a 510(k) submission. Nothing you don't.