K-number	K792249
Device name	FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
Applicant	Intl. Diagnostic Technology
Product code	GOL
Device class	Class II
Decision date	Jan 23, 1980
Decision	Substantially Equivalent
Regulation	866.3510

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View the full FDA submission: accessdata.fda.gov

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FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD

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