Medical Device Manufacturer · US , San Jose , CA

Lin-Zhi International, Inc.

50 submissions · 49 cleared · Since 2002
50
Total
49
Cleared
1
Denied

Lin-Zhi International, Inc. — FDA 510(k) Submissions

Lin-Zhi International, Inc. has submitted 50 FDA 510(k) premarket notifications since 2002, of which 49 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Methadone, Enzyme Immunoassay, Amphetamine, Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Gas Chromatography, Methamphetamine . Use the specialty filter in the sidebar to narrow results.

50 devices
1–25 of 50
LZI Buprenorphine II Enzyme Immunoassay
K253082 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 2026 115d
LZI Fentanyl III Enzyme Immunoassay
K251634 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2025 20d
LZI Oxycodone III Enzyme Immunoassay
K202007 · DJG Enzyme Immunoassay, Opiates · Toxicology
Sep 2020 58d
LZI Fentanyl II Enzyme Immunoassay
K201938 · DJG Enzyme Immunoassay, Opiates · Chemistry
Aug 2020 25d
LZI Tramadol Enzyme Immunoassay
K201223 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2020 29d
LZI Cotinine II Enzyme Immunoassay
K192299 · MKU Enzyme Immunoassay,... · Toxicology
Nov 2019 90d
LZI Methadone II Enzyme Immunoassay
K192433 · DJR Enzyme Immunoassay,... · Toxicology
Oct 2019 29d
LZI Fentanyl Enzyme Immunoassay
K181159 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2018 216d
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
DEN170010 · QBK Meprobamate Test System · Toxicology
Apr 2018 423d
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · DJR Enzyme Immunoassay,... · Toxicology
Jun 2017 136d
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
K141320 · LDJ Enzyme Immunoassay,... · Toxicology
May 2015 373d
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
K141205 · DJG Enzyme Immunoassay, Opiates · Toxicology
Feb 2015 280d
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
K141055 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2014 50d
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652 · LAF Gas Chromatography,... · Toxicology
Mar 2014 289d
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
K133710 · DKB Calibrators, Drug Mixture · Toxicology
Feb 2014 79d
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · DKZ Enzyme Immunoassay,... · Toxicology
Feb 2014 244d
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2012 80d
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2012 56d
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
K113661 · LAF Gas Chromatography,... · Chemistry
Jan 2012 41d
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139 · DIO Enzyme Immunoassay,... · Chemistry
Nov 2011 29d
OPIATE ENZYME IMMUNOASSAY
K110298 · DJG Enzyme Immunoassay, Opiates · Chemistry
Jul 2011 164d
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
K110239 · LDJ Enzyme Immunoassay,... · Chemistry
Jun 2011 148d
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
K102210 · DKZ Enzyme Immunoassay,... · Chemistry
Dec 2010 145d
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
K101195 · DJG Enzyme Immunoassay, Opiates · Chemistry
Jul 2010 68d
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2009 125d
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