FDA 510(k)

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

Numéro K : K172627 · 2018-03-28

Date de décision2018-03-28

Code produitLCX

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Runbio Biotech Co.,Ltd. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K172627. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Runbio Biotech Co.,Ltd. The 510(k) number is K172627.

When did David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette receive FDA 510(k) clearance?

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

Who is the listed applicant for David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette?

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

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.

Essais cliniques associés

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Autres dossiers indiquant Runbio Biotech Co.,Ltd en tant que demandeur

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

Dispositifs connexes (Code : LCX)

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., LLC K242135Synthgene 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., LLC K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Source officielle

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