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FDA 510(k)

NATURALE HCG PREGNANCY TES

K-Number: K964002 · 1996-11-07

ApplicantMizuho USA, Inc.
Decision Date1996-11-07
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NATURALE HCG PREGNANCY TES 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 1996-11-07 under 510(k) number K964002. 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 NATURALE HCG PREGNANCY TES?

NATURALE HCG PREGNANCY TES is a medical device that received FDA 510(k) clearance on 1996-11-07. The listed applicant is Mizuho USA, Inc.. The 510(k) number is K964002.

When did NATURALE HCG PREGNANCY TES receive FDA 510(k) clearance?

NATURALE HCG PREGNANCY TES received FDA 510(k) clearance on 1996-11-07, under 510(k) number K964002.

Who is the listed applicant for NATURALE HCG PREGNANCY TES?

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 NATURALE HCG PREGNANCY TES?

The FDA product code for NATURALE HCG PREGNANCY TES 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 TESTK943859QUICK 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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