K-number	K801642
Device name	FIAX TEST KIT FOR THEOPHYLLINE QUANT.
Applicant	Intl. Diagnostic Technology
Product code	KLS
Device class	Class II
Decision date	Aug 27, 1980
Decision	Substantially Equivalent
Regulation	862.3880

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View the full FDA submission: accessdata.fda.gov

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FIAX TEST KIT FOR THEOPHYLLINE QUANT.

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