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FDA 510(k)

SEMEN ANALYSIS KIT

K-Number: K915229 · 1994-08-30

ApplicantHumagen Fertility Diagnostics, Inc.
Decision Date1994-08-30
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SEMEN ANALYSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Humagen Fertility Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-08-30 under 510(k) number K915229. 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 SEMEN ANALYSIS KIT?

SEMEN ANALYSIS KIT is a medical device that received FDA 510(k) clearance on 1994-08-30. The listed applicant is Humagen Fertility Diagnostics, Inc.. The 510(k) number is K915229.

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

SEMEN ANALYSIS KIT received FDA 510(k) clearance on 1994-08-30, under 510(k) number K915229.

Who is the listed applicant for SEMEN ANALYSIS KIT?

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

What is the FDA product code for SEMEN ANALYSIS KIT?

The FDA product code for SEMEN ANALYSIS KIT is POV.

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Other records listing Humagen Fertility Diagnostics, Inc. as applicant

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.

K012811BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-BK000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75K990941NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452LK990847INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

Related Devices (Code: POV)

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.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

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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