Home / 510(k) Clearances / K181968

510(k) K181968

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2018
Date Received
July 24, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Safecare Biotech (Hangzhou) Co., Ltd.

  • K242767 — Safecare Urinary Tract Infection Test (January 10, 2025)
  • K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (April 10, 2024)
  • K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (March 24, 2021)
  • K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (August 13, 2020)
  • K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (May 27, 2020)
  • K191924 — SAFECARE® THC Urine Strip Test (August 16, 2019)
  • K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (November 19, 2018)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

Other clearances for product code NFT

  • K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (March 9, 2026)
  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K252867 — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (October 9, 2025)
  • K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (September 12, 2025)
  • K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (August 27, 2025)
  • K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (August 15, 2025)
  • K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (April 4, 2025)
  • K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (February 27, 2025)
  • K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Ur (February 7, 2025)
  • K242498 — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (October 1, 2024)