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FDA 510(k)

MID STREAM PREGNANCY TEST

K-Number: K023037 · 2003-04-09

ApplicantAdvanced Diagnostics, Inc.
Decision Date2003-04-09
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MID STREAM PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-04-09 under 510(k) number K023037. 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 MID STREAM PREGNANCY TEST?

MID STREAM PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2003-04-09. The listed applicant is Advanced Diagnostics, Inc.. The 510(k) number is K023037.

When did MID STREAM PREGNANCY TEST receive FDA 510(k) clearance?

MID STREAM PREGNANCY TEST received FDA 510(k) clearance on 2003-04-09, under 510(k) number K023037.

Who is the listed applicant for MID STREAM PREGNANCY TEST?

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

What is the FDA product code for MID STREAM PREGNANCY TEST?

The FDA product code for MID STREAM PREGNANCY TEST is LCX.

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Other records listing Advanced Diagnostics, Inc. as applicant

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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

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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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