Atlas FDA

Lin-Zhi International, Inc.

50 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LZI Buprenorphine II Enzyme Immunoassay (K253082)Lin-Zhi International, Inc.2026-01-16
LZI Fentanyl III Enzyme Immunoassay (K251634)Lin-Zhi International, Inc.2025-06-18
LZI Oxycodone III Enzyme Immunoassay (K202007)Lin-Zhi International, Inc.2020-09-17
LZI Fentanyl II Enzyme Immunoassay (K201938)Lin-Zhi International, Inc.2020-08-07
LZI Tramadol Enzyme Immunoassay (K201223)Lin-Zhi International, Inc.2020-06-04
LZI Cotinine II Enzyme Immunoassay (K192299)Lin-Zhi International, Inc.2019-11-21
LZI Methadone II Enzyme Immunoassay (K192433)Lin-Zhi International, Inc.2019-10-04
LZI Fentanyl Enzyme Immunoassay (K181159)Lin-Zhi International, Inc.2018-12-03
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (DEN170010)Lin-Zhi International, Inc.2018-04-20
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators (K170416)Lin-Zhi International, Inc.2017-06-26
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320)Lin-Zhi International, Inc.2015-05-28
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 (K141205)Lin-Zhi International, Inc.2015-02-13
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) (K141055)Lin-Zhi International, Inc.2014-06-13
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652)Lin-Zhi International, Inc.2014-03-21
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (K133710)Lin-Zhi International, Inc.2014-02-21
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131653)Lin-Zhi International, Inc.2014-02-04
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS (K120763)Lin-Zhi International, Inc.2012-06-01
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS (K120761)Lin-Zhi International, Inc.2012-05-08
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661)Lin-Zhi International, Inc.2012-01-23
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS (K113139)Lin-Zhi International, Inc.2011-11-22
OPIATE ENZYME IMMUNOASSAY (K110298)Lin-Zhi International, Inc.2011-07-15
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL (K110239)Lin-Zhi International, Inc.2011-06-23
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS (K102210)Lin-Zhi International, Inc.2010-12-28
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS (K101195)Lin-Zhi International, Inc.2010-07-06
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS (K090844)Lin-Zhi International, Inc.2009-07-30
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS (K081008)Lin-Zhi International, Inc.2008-12-22
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS (K063024)Lin-Zhi International, Inc.2006-10-30
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS (K062242)Lin-Zhi International, Inc.2006-09-29
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K050988)Lin-Zhi International, Inc.2006-04-06
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K051058)Lin-Zhi International, Inc.2006-03-29
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS (K050945)Lin-Zhi International, Inc.2006-03-29
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088)Lin-Zhi International, Inc.2005-06-24
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS (K050733)Lin-Zhi International, Inc.2005-06-13
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885)Lin-Zhi International, Inc.2004-05-19
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) (K033866)Lin-Zhi International, Inc.2004-04-07
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) (K033094)Lin-Zhi International, Inc.2003-12-19
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) (K032764)Lin-Zhi International, Inc.2003-11-03
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) (K031797)Lin-Zhi International, Inc.2003-10-10
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 (K032461)Lin-Zhi International, Inc.2003-10-03
BENZODIAZEPINE ENZYME IMMUNOASSAY (K032365)Lin-Zhi International, Inc.2003-09-05
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K023316)Lin-Zhi International, Inc.2002-12-16
METHADONE ENZYME IMMUNOASSAY (K023317)Lin-Zhi International, Inc.2002-12-12
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 (K021887)Lin-Zhi International, Inc.2002-08-15
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K021449)Lin-Zhi International, Inc.2002-06-18
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) (K020395)Lin-Zhi International, Inc.2002-06-04
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) (K020368)Lin-Zhi International, Inc.2002-06-04
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 (K020254)Lin-Zhi International, Inc.2002-05-10
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) (K020763)Lin-Zhi International, Inc.2002-05-10
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K020769)Lin-Zhi International, Inc.2002-04-03

Track Lin-Zhi International, Inc. automatically

Every clearance here is in the API, with alerts when new ones post.