K-number	K830669
Device name	FIAX COMPLEMENT C4 TEST KIT
Applicant	Intl. Diagnostic Technology
Product code	DBI
Device class	Class II
Decision date	Apr 8, 1983
Decision	Substantially Equivalent
Regulation	866.5240

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View the full FDA submission: accessdata.fda.gov

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FIAX COMPLEMENT C4 TEST KIT

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