Name: Predicase
Price: 199 USD

K-number	K033786
Device name	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
Applicant	Ibl GmbH
Product code	JIT
Device class	Class II
Decision date	Feb 27, 2004
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

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