Data / Medical devices / United States / Lin-Zhi International, Inc.
Lin-Zhi International, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 37 510(k) clearances
Lin-Zhi International, Inc. is registered with the FDA (registration 3003610499) in Santa Clara, CA, United States. It lists 19 device types. The FDA files 37 510(k) clearances under its listings, the newest dated June 18, 2025. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003610499
- Address
- 2945 Oakmead Village Ct, Santa Clara, CA, United States, 95051
- Owner or operator
- LIN-ZHI INTERNATIONAL, INC. (9049436)
- Roles
- Manufacturer
- First device listed
- November 27, 2002
- Registered through
- 2027
- Brand names listed
- 6-Acetylmorphine DAU Calibrators, 6-Acetylmorphine DAU Controls, 6-Acetylmorphine Enzyme Immunoassay, Amphetamines 500 DAU Calibrators, Amphetamines 500 DAU Controls, Amphetamines 500 Enzyme Immunoassay, Amphetamines DAU Calibrators, Amphetamines DAU Controls and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2025 | K251634 | LZI Fentanyl III Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| September 17, 2020 | K202007 | LZI Oxycodone III Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| August 7, 2020 | K201938 | LZI Fentanyl II Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 4, 2020 | K201223 | LZI Tramadol Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 21, 2019 | K192299 | LZI Cotinine II Enzyme Immunoassay | MKU | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 4, 2019 | K192433 | LZI Methadone II Enzyme Immunoassay | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 3, 2018 | K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 20, 2018 | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | QBK | Unknown | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 26, 2017 | K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 28, 2015 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | LDJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| February 13, 2015 | K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 13, 2014 | K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| March 21, 2014 | K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | LAF | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| February 21, 2014 | K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | DKB | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| February 4, 2014 | K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 1, 2012 | K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 8, 2012 | K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| January 23, 2012 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | LAF | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 22, 2011 | K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 15, 2011 | K110298 | OPIATE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 23, 2011 | K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 28, 2010 | K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 6, 2010 | K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| July 30, 2009 | K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 22, 2008 | K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS | DJG | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 19, 2003 | K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| November 3, 2003 | K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 10, 2003 | K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| October 3, 2003 | K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | DIC | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| September 5, 2003 | K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| January 21, 2003 | K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | JXN | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 16, 2002 | K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| December 12, 2002 | K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| June 4, 2002 | K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | DKZ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | DIO | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | LCM | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
| April 3, 2002 | K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | Lin-Zhi International, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 11, 2019 | 82011 | Class III | Terminated | 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 detergent residue was | Shelf life of the product may be reduced due to degradation of the assay. | accessdata.fda.gov |
| February 18, 2014 | 67607 | Class III | Terminated | 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 Calibrator is used for | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). | accessdata.fda.gov |
| February 6, 2014 | 67521 | Class II | Terminated | 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 THC version c) DAU nega | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products. | accessdata.fda.gov |
| October 3, 2013 | 66542 | Class III | Terminated | 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 with sodium azide as a | Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution. | accessdata.fda.gov |
| October 11, 2011 | 60757 | Not yet classified | Terminated | 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: morphine, 50 phencyclidine, | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. | accessdata.fda.gov |
| September 8, 2011 | 60750 | Not yet classified | Terminated | 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 nicotinamide adenine dinu | Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned. | accessdata.fda.gov |
| August 23, 2011 | 60743 | Not yet classified | Terminated | 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 abuse detection. | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings. | accessdata.fda.gov |
| August 5, 2011 | 60691 | Not yet classified | Terminated | 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) Controls are for use as co | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators. | accessdata.fda.gov |
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Updated June 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.