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Lin-Zhi International Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
50
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1256-2019Class IIIEthyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) ProduJanuary 11, 2019
Z-1270-2014Class IIISingle Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnFebruary 18, 2014
Z-1178-2014Class IICannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-steriFebruary 6, 2014
Z-1179-2014Class IICannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-steriFebruary 6, 2014
Z-0386-2014Class IIISingle Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro DiagnosticOctober 3, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K253082LZI Buprenorphine II Enzyme ImmunoassayJanuary 16, 2026
K251634LZI Fentanyl III Enzyme ImmunoassayJune 18, 2025
K202007LZI Oxycodone III Enzyme ImmunoassaySeptember 17, 2020
K201938LZI Fentanyl II Enzyme ImmunoassayAugust 7, 2020
K201223LZI Tramadol Enzyme ImmunoassayJune 4, 2020
K192299LZI Cotinine II Enzyme ImmunoassayNovember 21, 2019
K192433LZI Methadone II Enzyme ImmunoassayOctober 4, 2019
K181159LZI Fentanyl Enzyme ImmunoassayDecember 3, 2018
DEN170010LZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayApril 20, 2018
K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsJune 26, 2017
K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI OralMay 28, 2015
K141205LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 MFebruary 13, 2015
K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)June 13, 2014
K131652LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSMarch 21, 2014
K133710LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLSFebruary 21, 2014
K131653LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSFebruary 4, 2014
K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSJune 1, 2012
K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLMay 8, 2012
K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSJanuary 23, 2012
K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSNovember 22, 2011