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FDA 510(k)

FACT PLUS ONE-STEP PREGNANCY TEST KIT

K-Number: K042280 · 2004-09-10

ApplicantUnipath , Ltd.
Decision Date2004-09-10
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FACT PLUS ONE-STEP PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K042280. 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 FACT PLUS ONE-STEP PREGNANCY TEST KIT?

FACT PLUS ONE-STEP PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Unipath , Ltd.. The 510(k) number is K042280.

When did FACT PLUS ONE-STEP PREGNANCY TEST KIT receive FDA 510(k) clearance?

FACT PLUS ONE-STEP PREGNANCY TEST KIT received FDA 510(k) clearance on 2004-09-10, under 510(k) number K042280.

Who is the listed applicant for FACT PLUS ONE-STEP PREGNANCY TEST KIT?

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

What is the FDA product code for FACT PLUS ONE-STEP PREGNANCY TEST KIT?

The FDA product code for FACT PLUS ONE-STEP PREGNANCY TEST KIT is LCX.

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Other records listing Unipath , Ltd. 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK041404CLEARBLUE EASY EASY READ PREGNANCY TESTK040341CLEARBLUE EASY EARLIEST RESULTS 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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