K983113

Substantially Equivalent

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

Applicant: Syntron Bioresearch, Inc.
Product code: CEP
Advisory panel: Clinical Chemistry
Date received: 1998-09-04
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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