K-number	K790464
Device name	FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO
Applicant	Intl. Diagnostic Technology
Product code	GLZ
Device class	Class II
Decision date	Jun 13, 1979
Decision	Substantially Equivalent
Regulation	866.3780

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View the full FDA submission: accessdata.fda.gov

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FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO

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