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FDA 510(k)

Acro HCG Pregnancy Rapid Test

K-Number: K180771 · 2018-05-18

ApplicantAcro Biotech, Inc.
Decision Date2018-05-18
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Acro HCG Pregnancy Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biotech, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180771. 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 Acro HCG Pregnancy Rapid Test?

Acro HCG Pregnancy Rapid Test is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Acro Biotech, Inc.. The 510(k) number is K180771.

When did Acro HCG Pregnancy Rapid Test receive FDA 510(k) clearance?

Acro HCG Pregnancy Rapid Test received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180771.

Who is the listed applicant for Acro HCG Pregnancy Rapid Test?

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

What is the FDA product code for Acro HCG Pregnancy Rapid Test?

The FDA product code for Acro HCG Pregnancy Rapid Test is LCX.

Other records listing Acro Biotech, 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.

K172512ACRO HCG Pregnancy Rapid 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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