FDA.reportPublic FDA data

510(k) K181551

Device
DAVID 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
Applicant
Runbio BioTech Co.,Ltd
510(k) number
K181551
Product code
LCX  
Decision
Substantially Equivalent (SESE)
Decision date
2019-02-22
Date received
2018-06-13
Regulation
862.1155
Classification name
Kit, Test, Pregnancy, Hcg, Over The Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lyn Chen
Address
Rongsheng Technological Zone, University Rd. Shantou CN 515063 515063

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LCX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.2025-09-09
K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.2025-07-15
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC2025-02-13
K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.2025-01-31
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLC2025-01-15
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.2024-12-20
K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)Anhui Deepblue Medical Technology Co., Ltd.2024-10-11
K241978Shinetell Digital Pregnancy TestHangzhou AllTest Biotech Co., Ltd.2024-08-13
K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamGuangzhou Decheng Biotechnology Co., Ltd.2024-06-21
K232715Distinct® Digital Pregnancy TestACON Laboratories, Inc.2024-05-31
K233624HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream RxHangzhou Aichek Medical Technology Co., Ltd.2024-04-12
K234152ACESO Early Pregnancy TestAceso Laboratories, Inc.2024-04-05
K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamAssure Tech. (Hangzhou) Co, Ltd.2024-02-05
K240025Clearblue® Early Detection Pregnancy TestSpd Swiss Precision Diagnostics GmbH2024-01-31
K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IINantong Egens Biotechnology Co., Ltd.2024-01-26

Legacy Summary#

summary

FDA Review#

Decision Summary