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FDA 510(k)

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

K-Number: K041240 · 2004-06-02

ApplicantFertility Solutions, Inc.
Decision Date2004-06-02
Product CodeNRF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED is the device name listed in this FDA 510(k) record. The listed applicant is Fertility Solutions, Inc.. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K041240. The device is classified under product code NRF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED?

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Fertility Solutions, Inc.. The 510(k) number is K041240.

When did SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED receive FDA 510(k) clearance?

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED received FDA 510(k) clearance on 2004-06-02, under 510(k) number K041240.

Who is the listed applicant for SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED?

The FDA 510(k) record lists Fertility Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED?

The FDA product code for SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED is NRF.

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Official Source

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