# Lin-Zhi International, Inc.

- Location (FDA's records): Synnyvale, CA
- FDA decisions: 50 (2002–2026): 49 510(k) clearances and 1 De Novo grant
- Product codes: DJG (16), DKZ (5), DJR (5), DIO (4), LDJ (3), DLJ (3), LAF (3), DIS (2), DKB (2), JXM (1), JXN (1), DLG (1)
- 510(k) review time since 2016: median 44 days, against 31 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 67 (35 its own); citations of its devices by later devices: 52 (35 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Reagents, Inc.: 14 (https://510kreport.com/company/diagnostic-reagents)
- Microgenics Corp.: 6 (https://510kreport.com/company/microgenics)
- OraSure Technologies, Inc.: 5 (https://510kreport.com/company/orasure-technologies)
- Syva Co.: 3 (https://510kreport.com/company/syva)
- Immunalysis Corporation: 1 (https://510kreport.com/company/immunalysis)
- Syva Co., Dade Behring, Inc.: 1 (https://510kreport.com/company/syva-co-dade-behring)
- Dynagen, Inc.: 1 (https://510kreport.com/company/dynagen)
- Ark Diagnostics, Inc.: 1 (https://510kreport.com/company/ark-diagnostics)

## Firms that cite its devices most
- Immunalysis Corporation: 9 (https://510kreport.com/company/immunalysis)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Carolina Liquid Chemistries Corp.: 1 (https://510kreport.com/company/carolina-liquid-chemistries)
- Medtest DX: 1 (https://510kreport.com/company/medtest-dx)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)
- Infrared Laboratory Systems, LLC (Dba Synermed): 1 (https://510kreport.com/company/infrared-laboratory-systems-dba-synermed)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)
- Diatron Group: 1 (https://510kreport.com/company/diatron-group)

## Its most-cited devices
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (2005), cited by 6
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit) (2002), cited by 3
- K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit) (2002), cited by 3
- K110239: Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control (2011), cited by 2
- K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls (2012), cited by 2
- K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls (2006), cited by 2

## Recent decisions
- K253082: LZI Buprenorphine II Enzyme Immunoassay (Jan 16, 2026)
- K251634: LZI Fentanyl III Enzyme Immunoassay (Jun 18, 2025)
- K202007: LZI Oxycodone III Enzyme Immunoassay (Sep 17, 2020)
- K201938: LZI Fentanyl II Enzyme Immunoassay (Aug 7, 2020)
- K201223: LZI Tramadol Enzyme Immunoassay (Jun 4, 2020)
- K192299: LZI Cotinine II Enzyme Immunoassay (Nov 21, 2019)
- K192433: LZI Methadone II Enzyme Immunoassay (Oct 4, 2019)
- K181159: LZI Fentanyl Enzyme Immunoassay (Dec 3, 2018)

Source page: https://510kreport.com/company/lin-zhi-international