K-number	K050352
Device name	IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
Applicant	Ameritek Research, LLC
Product code	JTO
Device class	Class I
Decision date	Sep 1, 2005
Decision	Substantially Equivalent
Regulation	866.2660

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View the full FDA submission: accessdata.fda.gov

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IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

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