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FDA 510(k)

MULTI-USE ELECTRONIC PREGNANCY TEST

K-Number: K060825 · 2006-06-19

ApplicantMizuho USA, Inc.
Decision Date2006-06-19
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTI-USE ELECTRONIC PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho USA, Inc.. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K060825. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-USE ELECTRONIC PREGNANCY TEST?

MULTI-USE ELECTRONIC PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Mizuho USA, Inc.. The 510(k) number is K060825.

When did MULTI-USE ELECTRONIC PREGNANCY TEST receive FDA 510(k) clearance?

MULTI-USE ELECTRONIC PREGNANCY TEST received FDA 510(k) clearance on 2006-06-19, under 510(k) number K060825.

Who is the listed applicant for MULTI-USE ELECTRONIC PREGNANCY TEST?

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

What is the FDA product code for MULTI-USE ELECTRONIC PREGNANCY TEST?

The FDA product code for MULTI-USE ELECTRONIC PREGNANCY TEST is LCX.

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Other records listing Mizuho USA, 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.

K043231PROOF POSITIVE ELECTRONIC PREGNANCY TESTK000844ABSOLUTE HCG PREGNANCY TESTK964002NATURALE HCG PREGNANCY TESK943859QUICK CHECKER HCG PREGNANCY TESTK945568HCG MIDSTREAM PREGNANCY TESTK931997HCG MIDSTREAM PREGNANCY TEST

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Related Devices (Code: LCX)

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.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

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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