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FDA 510(k)

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS

K-Number: K063864 · 2007-03-26

ApplicantMedical Electronic Systems , Ltd.
Decision Date2007-03-26
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2007-03-26 under 510(k) number K063864. 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 QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS?

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS is a medical device that received FDA 510(k) clearance on 2007-03-26. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K063864.

When did QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS receive FDA 510(k) clearance?

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS received FDA 510(k) clearance on 2007-03-26, under 510(k) number K063864.

Who is the listed applicant for QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS?

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

What is the FDA product code for QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS?

The FDA product code for QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS is POV.

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Other records listing Medical Electronic Systems , Ltd. as applicant

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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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