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510(k) K181159

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2018
Date Received
May 1, 2018
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 Lin-Zhi International, Inc.

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  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K202007 — LZI Oxycodone III Enzyme Immunoassay (September 17, 2020)
  • 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)
  • 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)

Other clearances for product code DJG

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  • 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)
  • 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)