K-number	K974508
Device name	DBEST ONE-STEP OVULATION TEST
Applicant	Ameritek, Inc.
Product code	CEP
Device class	Class I
Decision date	Feb 2, 1998
Decision	Substantially Equivalent
Regulation	862.1485

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View the full FDA submission: accessdata.fda.gov

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DBEST ONE-STEP OVULATION TEST

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