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510(k) K240654

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2024
Date Received
March 7, 2024
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 Safecare Biotech (Hangzhou) Co., Ltd.

  • K242767 — Safecare Urinary Tract Infection Test (January 10, 2025)
  • 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)
  • K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (August 20, 2018)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

Other clearances for product code NGL

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  • K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (April 15, 2025)
  • 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)