Lin-Zhi International, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LZI Buprenorphine II Enzyme Immunoassay, LZI Fentanyl III Enzyme Immunoassay, LZI Oxycodone III Enzyme Immunoassay
50
Total
49
Cleared
1
Denied
FDA 510(k) Regulatory Record - Lin-Zhi International, Inc. Toxicology ✕
38 devices
Cleared
Jan 16, 2026
LZI Buprenorphine II Enzyme Immunoassay
Toxicology
115d
Cleared
Jun 18, 2025
LZI Fentanyl III Enzyme Immunoassay
Toxicology
20d
Cleared
Sep 17, 2020
LZI Oxycodone III Enzyme Immunoassay
Toxicology
58d
Cleared
Jun 04, 2020
LZI Tramadol Enzyme Immunoassay
Toxicology
29d
Cleared
Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
Toxicology
90d
Cleared
Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
Toxicology
29d
Cleared
Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
Toxicology
216d
Not Cleared
Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
Toxicology
423d
Cleared
Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100...
Toxicology
136d
Cleared
May 28, 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids...
Toxicology
373d
Cleared
Feb 13, 2015
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID...
Toxicology
280d
Cleared
Jun 13, 2014
LZI HYDROCODONE
Toxicology
50d
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