FERTELL MALE FERTILITY TEST— 510(k) K041039

Substantially Equivalent

Genosis , Ltd.

FDA 510(k) clearance K041039 for FERTELL MALE FERTILITY TEST, Substantially Equivalent on 2004-07-20. Applicant: Genosis , Ltd.. Device class: 2.

Clearance details

Applicant: Genosis , Ltd.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2004-04-22
Decision date: 2004-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.