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FDA 510(k)

ONE STEP MIDSTREAM HCG PREGNANCY TEST

K-Number: K974059 · 1998-04-09

ApplicantInternational Newtech Development, Inc.
Decision Date1998-04-09
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE STEP MIDSTREAM HCG PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is International Newtech Development, Inc.. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K974059. 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 ONE STEP MIDSTREAM HCG PREGNANCY TEST?

ONE STEP MIDSTREAM HCG PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K974059.

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

ONE STEP MIDSTREAM HCG PREGNANCY TEST received FDA 510(k) clearance on 1998-04-09, under 510(k) number K974059.

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

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

What is the FDA product code for ONE STEP MIDSTREAM HCG PREGNANCY TEST?

The FDA product code for ONE STEP MIDSTREAM HCG PREGNANCY TEST is LCX.

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Other records listing International Newtech Development, 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.

K993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)K974060MINISTRIP/ SERUM AND URINE COMBO HCG TESTK974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCGK970176HCG CONTROLSK963133PS-UNIT CASSETTE/SERUM HCGK963132MINI STRIP/SERUM HCG

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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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