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510(k) K231904

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard by Co-Innovation Biotech Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
June 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Co-Innovation Biotech Co., Ltd.

  • K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (May 22, 2024)
  • K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapi (January 17, 2024)
  • K213808 — Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovat (April 5, 2022)
  • K153050 — Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (April 26, 2016)
  • K142800 — Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (December 11, 2014)
  • K140748 — ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD (August 20, 2014)
  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K131110 — ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPC (January 15, 2014)
  • K132085 — ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM (November 12, 2013)

Other clearances for product code DJG

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  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)
  • K232597 — LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette (January 9, 2024)