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FDA 510(k)

GENERAL SEMEN ANALYSIS KIT

K-Number: K071737 · 2007-10-25

ApplicantDyn-Bioshaf (2006) , Ltd.
Decision Date2007-10-25
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENERAL SEMEN ANALYSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dyn-Bioshaf (2006) , Ltd.. It received FDA 510(k) clearance on 2007-10-25 under 510(k) number K071737. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERAL SEMEN ANALYSIS KIT?

GENERAL SEMEN ANALYSIS KIT is a medical device that received FDA 510(k) clearance on 2007-10-25. The listed applicant is Dyn-Bioshaf (2006) , Ltd.. The 510(k) number is K071737.

When did GENERAL SEMEN ANALYSIS KIT receive FDA 510(k) clearance?

GENERAL SEMEN ANALYSIS KIT received FDA 510(k) clearance on 2007-10-25, under 510(k) number K071737.

Who is the listed applicant for GENERAL SEMEN ANALYSIS KIT?

The FDA 510(k) record lists Dyn-Bioshaf (2006) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERAL SEMEN ANALYSIS KIT?

The FDA product code for GENERAL SEMEN ANALYSIS KIT is POV.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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