Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003610499

FEI Number

3003610499

Entity Name

LIN-ZHI INTERNATIONAL, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

2945 Oakmead Village Ct, Santa Clara, CA 95051, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LIN-ZHI INTERNATIONAL, INC. (Owner Number: 9049436)

Owner / Operator Contact Address

2945 Oakmead Village Court, --, Santa Clara, CA 95051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Benzodiazepine DAU Controls Benzodiazepine DAU Calibrators Benzodiazepine Enzyme Immunoassay Ethyl Alcohol DAU Calibrators Ethyl Alcohol Enzymatic Assay Ethyl Alcohol DAU Controls Methadone DAU Controls Propoxyphene DAU Calibrators Propoxyphene DAU Controls Methadone DAU Calibratos Ecstasy DAU Controls Ecstasy DAU Calibrators Ecstasy Enzyme Immunoassay LZI Fentanyl II Enzyme Immunoassay Methadone Enzyme Immunoassay Methadone Metabolite (EDDP) Enzyme Immunoassay Methadone Metabolite (EDDP) 100 DAU Calibrators Methadone Metabolite (EDDP) 300 DAU Calibrators LZI Oxycodone III Enzyme Immunoassay Buprenorphine Enzyme Immunoassay Norbuprenorphine DAU Controls Norbuprenorphine DAU Calibrator LZI Methadone II Enzyme Immunoassay LZI Fentanyl III Enzyme Immunoassay Oral Fluid Cannabinoids (OF THC) Controls Oral Fluid Cannabinoids (OF THC) Calibrators Oral Fluid Cannabinoid Enzyme Immunoassay Methadone Metabolite DAU Calibrators Methadone Metabolite DAU Controls Methadone Metabolite Enzyme Immunoassay Phencyclidine DAU Controls Cocaine Metabolite DAU Controls Amphetamines DAU Controls Opiate DAU Calibrators Amphetamines DAU Calibrators Opiate DAU Controls Cocaine Metabolite DAU Calibrators Phencyclidine DAU Calibrators Norfentanyl DAU Calibrator LZI Methadone II Calibrators (Urine) LZI Oxycodone (300) Calibrators (Urine) Carisprodol Metabolite (Meprobamate) DAU Calibrators LZI Tramadol Calibrators (Urine) LZI Cotinine II Calibrators (Urine) LZI Oxycodone (100) Calibrators (Urine) LZI Fentanyl Calibrator Multi-Analyte Set F Drug of Abuse Calibrators Multi-Analyte Set D Drug of Abuse Calibrators Multi-Analyte Set E Drug of Abuse Calibrators Methamphetamine Enzyme Immunoassay Methamphetamine DAU Calibrators Methamphetamine DAU Controls 6-Acetylmorphine DAU Calibrators 6-Acetylmorphine DAU Controls 6-Acetylmorphine Enzyme Immunoassay Opiate 2000 DAU Calibrators Opiate 2000 DAU Controls Opiate 2000 Enzyme Immunoassay Propoxyphene Enzyme Immunoassay Opiate Enzyme Immunoassay Oxycodone Enzyme Immunoassay Oxycodone DAU Calibrators Oxycodone DAU Controls Amphetamines Enzyme Immunoassay Amphetamines 500 DAU Calibrators Amphetamines 500 DAU Controls Amphetamines 500 Enzyme Immunoassay Fentanyl Enzyme Immunoassay Cocaine Metabolite 150 DAU Controls Cocaine Metabolite 150 DAU Calibrators Cocaine Metabolite 150 Enzyme Immunoassay Multi-Analyte Set A Urine Drug of Abuse Calibrators Multi-Analyte Set C Urine Drug of Abuse Calibrators Multi-Analyte Set A Urine Drug of Abuse Controls Multi-Analyte Set C Urine Drug of Abuse Controls Multi-Analyte Set B Urine Drug of Abuse Controls Multi-Analyte Set B Urine Drug of Abuse Calibrators LZI Tramadol Enzyme Immunoassay Phencyclidine Enzyme Immunoassay Oral Fluid 6-Acetylmorphine Controls Oral Fluid 6-Acetylmorphine Calibrators Oral Fluid 6-Acetylmorphine Enzyme Immunoassay Oral Fluid Amphetamine Calibrators Oral Fluid Amphetamine Enzyme Immunoassay Oral Fluid Amphetamine Controls Carisprodol Metabolite (Meprobamate) DAU Controls Methadone Metabolite 100 DAU Controls LZI Methadone II Controls (Urine) Methadone Metabolite 300 DAU Controls LZI Cotinine II Controls (Urine) Norfentanyl DAU Controls LZI Oxycodone (100) Controls (Urine) LZI Tramadol Controls (Urine) LZI Oxycodone (300) Controls (Urine) LZI Fentanyl Controls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2006-08-03
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2006-08-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2006-08-03
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2006-08-03
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2006-08-03
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2006-08-03
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2006-08-03
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2006-08-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2006-08-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2020-09-01
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2017-12-27
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-12-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2020-09-18
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-10-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2025-09-11
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2016-04-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2016-04-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-04-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2002-11-27
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2002-11-27
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2008-01-17
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-01-17
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2018-12-03
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-03-21
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-04-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2016-04-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2016-04-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2018-12-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2016-04-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-04-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2020-09-01
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2008-01-17
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-12-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2016-04-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2016-04-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2016-04-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2016-04-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2016-04-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2016-04-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2018-10-08

Official Correspondent

MARIE LIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LIN-ZHI INTERNATIONAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27
K970265	Drial Consultants, Inc.	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	1997-04-08
K051161	Quest Diagnostics, Inc.	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	2005-11-22
K122904	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	2012-11-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003610499. Last updated year: 2026. Please use registration number 3003610499 when referencing this establishment in official correspondence.