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510(k) K251634

LZI Fentanyl III Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
May 29, 2025
Clearance Type
Special
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 Lin-Zhi International, Inc.

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  • K201938 — LZI Fentanyl II Enzyme Immunoassay (August 7, 2020)
  • K201223 — LZI Tramadol Enzyme Immunoassay (June 4, 2020)
  • K192299 — LZI Cotinine II Enzyme Immunoassay (November 21, 2019)
  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K181159 — LZI Fentanyl Enzyme Immunoassay (December 3, 2018)
  • DEN170010 — LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (April 20, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K141320 — LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali (May 28, 2015)

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  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 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)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 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)