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FDA 510(k)

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

K-Number: K110889 · 2011-06-20

ApplicantInd Diagnostics, Inc.
Decision Date2011-06-20
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-06-20 under 510(k) number K110889. 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 IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)?

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) is a medical device that received FDA 510(k) clearance on 2011-06-20. The listed applicant is Ind Diagnostics, Inc.. The 510(k) number is K110889.

When did IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) receive FDA 510(k) clearance?

IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) received FDA 510(k) clearance on 2011-06-20, under 510(k) number K110889.

Who is the listed applicant for IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)?

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

What is the FDA product code for IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)?

The FDA product code for IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) 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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Other records listing Ind Diagnostics, 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.

K113506IND ONE STEP OCCULT BLOOD (FOB) TEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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