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FDA 510(k)

HCG MIDSTREAM PREGNANCY TEST

K-Number: K945568 · 1995-01-17

ApplicantMizuho USA, Inc.
Decision Date1995-01-17
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG MIDSTREAM 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 1995-01-17 under 510(k) number K945568. 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 HCG MIDSTREAM PREGNANCY TEST?

HCG MIDSTREAM PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Mizuho USA, Inc.. The 510(k) number is K945568.

When did HCG MIDSTREAM PREGNANCY TEST receive FDA 510(k) clearance?

HCG MIDSTREAM PREGNANCY TEST received FDA 510(k) clearance on 1995-01-17, under 510(k) number K945568.

Who is the listed applicant for HCG MIDSTREAM 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 HCG MIDSTREAM PREGNANCY TEST?

The FDA product code for HCG MIDSTREAM 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.

K060825MULTI-USE ELECTRONIC PREGNANCY TESTK043231PROOF POSITIVE ELECTRONIC PREGNANCY TESTK000844ABSOLUTE HCG PREGNANCY TESTK964002NATURALE HCG PREGNANCY TESK943859QUICK CHECKER HCG 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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