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FDA 510(k)

GENERAL SEMEN ANALYSIS (GSA) KIT

K-Number: K024337 · 2003-07-03

ApplicantBioshaf , Ltd.
Decision Date2003-07-03
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENERAL SEMEN ANALYSIS (GSA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioshaf , Ltd.. It received FDA 510(k) clearance on 2003-07-03 under 510(k) number K024337. 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 (GSA) KIT?

GENERAL SEMEN ANALYSIS (GSA) KIT is a medical device that received FDA 510(k) clearance on 2003-07-03. The listed applicant is Bioshaf , Ltd.. The 510(k) number is K024337.

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

GENERAL SEMEN ANALYSIS (GSA) KIT received FDA 510(k) clearance on 2003-07-03, under 510(k) number K024337.

Who is the listed applicant for GENERAL SEMEN ANALYSIS (GSA) KIT?

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

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

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

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Official Source

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

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