Company ยท US
Lin-Zhi International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (1 in 12 months)
9recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 17 |
| DJR | Enzyme Immunoassay, Methadone | 5 |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 |
| DKB | Calibrators, Drug Mixture | 4 |
| DLJ | Calibrators, Drug Specific | 4 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 2 |
| DIF | Drug Mixture Control Materials | 1 |
| DLG | Coating, Liquid, Glc | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LAS | Drug Specific Control Materials | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 1 |
| QBK | Meprobamate Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K253082 | LZI Buprenorphine II Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Jun 18, 2025 | K251634 | LZI Fentanyl III Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Sep 17, 2020 | K202007 | LZI Oxycodone III Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Aug 7, 2020 | K201938 | LZI Fentanyl II Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Jun 4, 2020 | K201223 | LZI Tramadol Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Nov 21, 2019 | K192299 | LZI Cotinine II Enzyme Immunoassay Lin-Zhi International, Inc. | MKU |
| Oct 4, 2019 | K192433 | LZI Methadone II Enzyme Immunoassay Lin-Zhi International, Inc. | DJR |
| Dec 3, 2018 | K181159 | LZI Fentanyl Enzyme Immunoassay Lin-Zhi International, Inc. | DJG |
| Apr 20, 2018 | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay Lin-Zhi International, Inc. | QBK |
| Jun 26, 2017 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators Lin-Zhi International, Inc. | DJR |
| May 28, 2015 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Lin-Zhi International, Inc. | LDJ |
| Feb 13, 2015 | K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 Lin-Zhi International, Inc. | DJG |
| Jun 13, 2014 | K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) Lin-Zhi International, Inc. | DJG |
| Mar 21, 2014 | K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc. | LAF |
| Feb 21, 2014 | K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS Lin-Zhi International, Inc. | DKB |
| Feb 4, 2014 | K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc. | DKZ |
| Jun 1, 2012 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS Lin-Zhi International, Inc. | DJG |
| May 8, 2012 | K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS Lin-Zhi International, Inc. | DJG |
| Jan 23, 2012 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS Lin-Zhi International, Inc. | LAF |
| Nov 22, 2011 | K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS Lin-Zhi International, Inc. | DIO |
| Jul 15, 2011 | K110298 | OPIATE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. | DJG |
| Jun 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL Lin-Zhi International, Inc. | LDJ |
| Dec 28, 2010 | K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS Lin-Zhi International, Inc. | DKZ |
| Jul 6, 2010 | K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJG |
| Jul 30, 2009 | K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJG |
| Dec 22, 2008 | K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc. | DJG |
| Oct 30, 2006 | K063024 | LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DKZ |
| Sep 29, 2006 | K062242 | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | LAF |
| Apr 6, 2006 | K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLG |
| Mar 29, 2006 | K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJR |
| Mar 29, 2006 | K050945 | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS Lin-Zhi International, Inc. | DIO |
| Jun 24, 2005 | K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DKB |
| Jun 13, 2005 | K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DJG |
| May 19, 2004 | K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc. | DIS |
| Apr 7, 2004 | K033866 | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) Lin-Zhi International, Inc. | DIO |
| Dec 19, 2003 | K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) Lin-Zhi International, Inc. | DKZ |
| Nov 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) Lin-Zhi International, Inc. | DIS |
| Oct 10, 2003 | K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc. | DJR |
| Oct 3, 2003 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc. | DIC |
| Sep 5, 2003 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. | JXM |
| Jan 21, 2003 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) Lin-Zhi International, Inc. | JXN |
| Dec 16, 2002 | K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
| Dec 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. | DJR |
| Aug 15, 2002 | K021887 | CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 Lin-Zhi International, Inc. | LDJ |
| Jun 18, 2002 | K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
| Jun 4, 2002 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) Lin-Zhi International, Inc. | DKZ |
| Jun 4, 2002 | K020368 | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) Lin-Zhi International, Inc. | DJG |
| May 10, 2002 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) Lin-Zhi International, Inc. | DIO |
| May 10, 2002 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 Lin-Zhi International, Inc. | LCM |
| Apr 3, 2002 | K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | DLJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2019 | Lin-Zhi International Inc Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit)
Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some Terminated |
DIC | K032461 |
| Mar 21, 2014 | Lin-Zhi International Inc Single Analyte DAU Calibrator (5 mL)
Norbuprenorphine: Cutoff Calibrator;
IVD - for in vitro diagnostic use only;
Lin-Zhi International
Sunnyvale, CA
The Norbuprenorphine Drug of Abuse (DAU) cutoff C Terminated |
DJG | K081008 |
| Mar 12, 2014 | Lin-Zhi International Inc Cannabinoids DAU Calibrator Control Level 1
(62.5 ng/mL)
This solution is prepared from non-sterile urine and should be handled as potentially infectious.
IVD;
The Cannabinoids (cTHC also known as T Terminated |
JJW | None listed |
| Mar 12, 2014 | Lin-Zhi International Inc Cannabinoids DAU Calibrator Control Level 1
(37.5 ng/mL)
This solution is prepared from non-sterile urine and should be handled as potentially infectious.
IVD;
The Cannabinoids (cTHC also known as T Terminated |
DLJ | K021449 |
| Nov 25, 2013 | Lin-Zhi International Inc Single Analyte Urine DAU Control (5 m L
Norbuprenorphine, Level II control
For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C.
Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine wi Terminated |
LAS | K081008 |
| Jan 25, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Calibrator (15 mL);
Multi-Analyte,Intermediate Calibrator;
for in-vitro diagnostic use only.
Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphin Terminated |
DKB | K051088 |
| Jan 25, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)
For in vitro diagnostic use only.
Lin-Zhi International, Inc..
670 Almanor Ave.
Sunnyvale, CA 94085
intended use: Drug a Terminated |
DKB | K051088 |
| Jan 24, 2012 | Lin-Zhi International Inc Barbiturate Enzyme Immunoassay; R1
Antibody/Substrate Reagent (5000 tests and 500 tests);
Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicot Terminated |
DIS | K032764 |
| Jan 23, 2012 | Lin-Zhi International Inc Multi-Analyte Urine DAU Control (15 mL);
Level 2, For in-vitro diagnostic use only.
Lin-Zhi International, Inc.
670 Almanor Ave.
Sunnyvale, CA 94085
Multi-Analyte Urine Drug of Drug Abuse (DAU) Cont Terminated |
DIF | K051088 |