Home / 510(k) Clearances / K250727

510(k) K250727

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup by Hangzhou AllTest Biotech Co., Ltd. — Product Code NFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
March 11, 2025
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 Hangzhou AllTest Biotech Co., Ltd.

  • K252607 — AllTest Urinary Tract Infection Test (October 30, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (February 27, 2025)
  • K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (September 27, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (June 17, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K233417 — AllTest Fentanyl Urine Test Cassette (October 26, 2023)
  • K231698 — AllTest Fentanyl Rapid Test (Urine) (July 31, 2023)

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)
  • 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)
  • K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (September 27, 2024)