CLEARPLAN EASY OVULATION TEST— 510(k) K981271

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K981271 for CLEARPLAN EASY OVULATION TEST, Substantially Equivalent on 1998-06-25. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Product code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1998-04-07
Decision date: 1998-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, GB

Download summary PDF View on FDA.gov ↗

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