SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED— 510(k) K041240

Name: FDA 510(k) clearance K041240
Creator: U.S. Food and Drug Administration
Published: 2004-06-02

Substantially Equivalent

Fertility Solutions, Inc.

FDA 510(k) clearance K041240 for SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED, Substantially Equivalent on 2004-06-02. Applicant: Fertility Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Fertility Solutions, Inc.
Product code: Code NRF
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2004-05-11
Decision date: 2004-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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