FDA 510(k) Applications Submitted by Lin-Zhi International, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K110239 01/26/2011 LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL Lin-Zhi International, Inc.
K110298 02/01/2011 OPIATE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K170416 02/10/2017 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators Lin-Zhi International, Inc.
K120763 03/13/2012 LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS Lin-Zhi International, Inc.
K120761 03/13/2012 LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS Lin-Zhi International, Inc.
K141055 04/24/2014 LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) Lin-Zhi International, Inc.
K101195 04/29/2010 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K181159 05/01/2018 LZI Fentanyl Enzyme Immunoassay Lin-Zhi International, Inc.
K201223 05/06/2020 LZI Tramadol Enzyme Immunoassay Lin-Zhi International, Inc.
K141205 05/09/2014 LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 Lin-Zhi International, Inc.
K131653 06/05/2013 LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc.
K131652 06/05/2013 LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc.
K201938 07/13/2020 LZI Fentanyl II Enzyme Immunoassay Lin-Zhi International, Inc.
K202007 07/21/2020 LZI Oxycodone III Enzyme Immunoassay Lin-Zhi International, Inc.
K102210 08/05/2010 LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS Lin-Zhi International, Inc.
K192299 08/23/2019 LZI Cotinine II Enzyme Immunoassay Lin-Zhi International, Inc.
K113139 10/24/2011 LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS Lin-Zhi International, Inc.
K133710 12/04/2013 LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS Lin-Zhi International, Inc.
K113661 12/13/2011 LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS Lin-Zhi International, Inc.
K141320 05/20/2014 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls Lin-Zhi International, Inc.
K032461 08/11/2003 ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc.
K050733 03/17/2005 OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K050945 04/14/2005 ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS Lin-Zhi International, Inc.
K051058 04/26/2005 METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K051088 04/28/2005 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K031797 06/10/2003 METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc.
K032365 07/31/2003 BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K032764 09/05/2003 BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) Lin-Zhi International, Inc.
K033094 09/29/2003 ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) Lin-Zhi International, Inc.
K033866 12/12/2003 CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) Lin-Zhi International, Inc.
K033885 12/15/2003 BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc.
K021449 05/06/2002 CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K020769 03/07/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K020763 03/07/2002 COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) Lin-Zhi International, Inc.
K023317 10/03/2002 METHADONE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K023316 10/03/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K020254 01/24/2002 PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 Lin-Zhi International, Inc.
K020368 02/04/2002 OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) Lin-Zhi International, Inc.
K020395 02/06/2002 AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) Lin-Zhi International, Inc.
K021887 06/07/2002 CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 Lin-Zhi International, Inc.
K023795 11/13/2002 PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) Lin-Zhi International, Inc.
DEN170010 02/21/2017 LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay Lin-Zhi International, Inc.
K090844 03/27/2009 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K081008 04/10/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS Lin-Zhi International, Inc.
K050988 04/19/2005 OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K062242 08/02/2006 METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K063024 10/02/2006 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.


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