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FDA 510(k)

INVERNESS MEDICAL EARLY PREGNANCY TEST

K-Number: K002049 · 2000-07-27

ApplicantSelfcare, Inc.
Decision Date2000-07-27
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INVERNESS MEDICAL EARLY PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 2000-07-27 under 510(k) number K002049. 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 INVERNESS MEDICAL EARLY PREGNANCY TEST?

INVERNESS MEDICAL EARLY PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2000-07-27. The listed applicant is Selfcare, Inc.. The 510(k) number is K002049.

When did INVERNESS MEDICAL EARLY PREGNANCY TEST receive FDA 510(k) clearance?

INVERNESS MEDICAL EARLY PREGNANCY TEST received FDA 510(k) clearance on 2000-07-27, under 510(k) number K002049.

Who is the listed applicant for INVERNESS MEDICAL EARLY PREGNANCY TEST?

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

What is the FDA product code for INVERNESS MEDICAL EARLY PREGNANCY TEST?

The FDA product code for INVERNESS MEDICAL EARLY PREGNANCY TEST is LCX.

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Other records listing Selfcare, Inc. as applicant

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K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTK002134ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMK001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

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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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