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FDA 510(k)

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

K-Number: K172627 · 2018-03-28

ApplicantRunbio Biotech Co.,Ltd
Decision Date2018-03-28
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette is a medical device manufactured by Runbio Biotech Co.,Ltd. It received FDA 510(k) clearance on 2018-03-28 under approval number K172627. 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 David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette?

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by Runbio Biotech Co.,Ltd. The 510(k) number is K172627.

When was David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette approved by the FDA?

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette received FDA 510(k) clearance on 2018-03-28, under approval number K172627.

What company makes David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette?

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette is manufactured by Runbio Biotech Co.,Ltd.

What is the FDA product code for David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette?

The FDA product code for David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette is LCX.

Other Devices by Runbio Biotech Co.,Ltd

K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. 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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