Lin-Zhi International Inc
FDA Regulatory Profile
Lin-Zhi International Inc appears in FDA public data with 5 recalls, 50 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1256-2019, Class III) was initiated on January 11, 2019. Its most recent 510(k) clearance was granted on January 16, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 50
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1256-2019 | Class III | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Produ | January 11, 2019 |
| Z-1270-2014 | Class III | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagn | February 18, 2014 |
| Z-1178-2014 | Class II | Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-steri | February 6, 2014 |
| Z-1179-2014 | Class II | Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-steri | February 6, 2014 |
| Z-0386-2014 | Class III | Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic | October 3, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | January 16, 2026 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | June 18, 2025 |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | September 17, 2020 |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | August 7, 2020 |
| K201223 | LZI Tramadol Enzyme Immunoassay | June 4, 2020 |
| K192299 | LZI Cotinine II Enzyme Immunoassay | November 21, 2019 |
| K192433 | LZI Methadone II Enzyme Immunoassay | October 4, 2019 |
| K181159 | LZI Fentanyl Enzyme Immunoassay | December 3, 2018 |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | April 20, 2018 |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | June 26, 2017 |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral | May 28, 2015 |
| K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 M | February 13, 2015 |
| K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | June 13, 2014 |
| K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | March 21, 2014 |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | February 21, 2014 |
| K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | February 4, 2014 |
| K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | June 1, 2012 |
| K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROL | May 8, 2012 |
| K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | January 23, 2012 |
| K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | November 22, 2011 |