Home / 510(k) Clearances / K150022

510(k) K150022

Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2015
Date Received
January 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Guangzhou Wondfo Biotech Co., Ltd.

  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K251289 — WELLlife COVID-19 Antigen Test Rx (October 22, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)
  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
  • K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup (December 3, 2018)
  • K173229 — Preview Digital Pregnancy Test (March 12, 2018)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)

Other clearances for product code LCX

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (February 13, 2025)
  • K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth (January 31, 2025)
  • K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse (January 15, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test (October 11, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)