CLEARPLANE EASY OVULATION TEST— 510(k) K013874

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K013874 for CLEARPLANE EASY OVULATION TEST, Substantially Equivalent on 2002-02-19. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 2001-11-21
Decision date: 2002-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.