EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT— 510(k) K970467

Name: FDA 510(k) clearance K970467
Creator: U.S. Food and Drug Administration
Published: 1997-03-18

Substantially Equivalent

Excel Scientific, Inc.

FDA 510(k) clearance K970467 for EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT, Substantially Equivalent on 1997-03-18. Applicant: Excel Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Excel Scientific, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1997-02-07
Decision date: 1997-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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