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510(k) K233417

AllTest Fentanyl Urine Test Cassette by Hangzhou AllTest Biotech Co., Ltd. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
October 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Hangzhou AllTest Biotech Co., Ltd.

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  • 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)
  • K231698 — AllTest Fentanyl Rapid Test (Urine) (July 31, 2023)

Other clearances for product code NGL

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  • K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (February 20, 2025)
  • K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche (February 6, 2025)
  • K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru (December 17, 2024)
  • K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfe (November 20, 2024)
  • K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (November 8, 2024)
  • K241869 — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSi (October 4, 2024)
  • K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl (August 14, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)