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FDA 510(k)

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

K-Number: K102760 · 2011-08-03

ApplicantAtlas Medical
Decision Date2011-08-03
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Medical. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K102760. 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 ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001?

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Atlas Medical. The 510(k) number is K102760.

When did ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 receive FDA 510(k) clearance?

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 received FDA 510(k) clearance on 2011-08-03, under 510(k) number K102760.

Who is the listed applicant for ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001?

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

What is the FDA product code for ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001?

The FDA product code for ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 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 Atlas Medical 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.

K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

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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