K-number	K844289
Device name	SERIES I/S INFECTIONS
Applicant	American Dade
Product code	KTN
Device class	Class II
Decision date	Nov 19, 1984
Decision	Substantially Equivalent
Regulation	866.5640

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Source

View the full FDA submission: accessdata.fda.gov

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SERIES I/S INFECTIONS

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