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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 a medical device manufactured by Acro Biotech, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval 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. It is manufactured by Acro Biotech, Inc.. The 510(k) number is K180771.

When was Acro HCG Pregnancy Rapid Test approved by the FDA?

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

What company makes Acro HCG Pregnancy Rapid Test?

Acro HCG Pregnancy Rapid Test is manufactured by Acro Biotech, Inc..

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

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

Related Clinical Trials

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Other Devices by Acro Biotech, Inc.

K172512ACRO HCG Pregnancy Rapid Test

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc. K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamHangzhou Clongene Biotech 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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