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FDA 510(k)

QUICK & SURE ONESTEP HOME PREGNANCY TEST

K-Number: K981892 · 1998-08-18

ApplicantAbacus Diagnostics
Decision Date1998-08-18
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICK & SURE ONESTEP HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Abacus Diagnostics. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K981892. 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 QUICK & SURE ONESTEP HOME PREGNANCY TEST?

QUICK & SURE ONESTEP HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Abacus Diagnostics. The 510(k) number is K981892.

When did QUICK & SURE ONESTEP HOME PREGNANCY TEST receive FDA 510(k) clearance?

QUICK & SURE ONESTEP HOME PREGNANCY TEST received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981892.

Who is the listed applicant for QUICK & SURE ONESTEP HOME PREGNANCY TEST?

The FDA 510(k) record lists Abacus Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUICK & SURE ONESTEP HOME PREGNANCY TEST?

The FDA product code for QUICK & SURE ONESTEP HOME PREGNANCY TEST is LCX.

Related Clinical Trials

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.

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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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