K-number	K990873
Device name	DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
Applicant	Ameritek, Inc.
Product code	JMT
Device class	Class I
Decision date	Sep 1, 1999
Decision	Substantially Equivalent
Regulation	862.1510

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View the full FDA submission: accessdata.fda.gov

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DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE

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