BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT— 510(k) K983113

Name: FDA 510(k) clearance K983113
Creator: U.S. Food and Drug Administration
Published: 1998-11-18

Substantially Equivalent

Syntron Bioresearch, Inc.

FDA 510(k) clearance K983113 for BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT, Substantially Equivalent on 1998-11-18. Applicant: Syntron Bioresearch, Inc.. Device class: 1.

Clearance details

Applicant: Syntron Bioresearch, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1998-09-04
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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