David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette

FDA 510(k) K172627 · Runbio Biotech Co.,Ltd

Substantially Equivalent

510(k) numberK172627

Submission

Device name
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Applicant
Runbio Biotech Co.,Ltd
Shantou, CN
Received
September 1, 2017
Decision date
March 28, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1155
Specialty
Clinical Chemistry

Other 510(k)s with product code LCX

510(k)DeviceApplicantDecision
K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.09/09/2025SE
K251053Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.07/15/2025SE
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional Assure Tech., LLC02/13/2025SE
K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional Nanjing Synthgene Medical Technology Co., Ltd.01/31/2025SE
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional Assure Tech., LLC01/15/2025SE
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional Andon Health Co, Ltd.12/20/2024SE
K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional Anhui Deepblue Medical Technology Co., Ltd.10/11/2024SE
K241978Shinetell Digital Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.08/13/2024SE
K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.06/21/2024SE
K232715Distinct® Digital Pregnancy TestLCX · Traditional ACON Laboratories, Inc.05/31/2024SE

More from ACON Laboratories, Inc.

510(k)DeviceDecision
K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test…LCX · Traditional 02/22/2019SE
K053236David Pregnancy Test (Midstream)LCX · Traditional 07/18/2006SE

Questions and answers

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

David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette (K172627) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 208 days after the submission was received.

What is the product code of K172627?

The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.