Medical Device Manufacturer · US , San Jose , CA

Lin-Zhi International, Inc. - FDA 510(k) Cleared Devices

50 submissions · 49 cleared · Since 2002
50
Total
49
Cleared
1
Denied
50 devices
26-50 of 50
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN...
K081008 · DJG
Toxicology · 256d
Cleared Oct 30, 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI...
K063024 · DKZ
Chemistry · 28d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · LAF
Chemistry · 58d
Cleared Apr 06, 2006
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K050988 · DLG
Toxicology · 352d
Cleared Mar 29, 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS &...
K050945 · DIO
Chemistry · 349d
Cleared Mar 29, 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058 · DJR
Toxicology · 337d
Cleared Jun 24, 2005
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K051088 · DKB
Chemistry · 57d
Cleared Jun 13, 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · DJG
Chemistry · 88d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · DIS
Toxicology · 156d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST...
K033866 · DIO
Toxicology · 117d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161...
K033094 · DKZ
Toxicology · 81d
Cleared Nov 03, 2003
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764 · DIS
Toxicology · 59d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT),...
K031797 · DJR
Toxicology · 122d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · DIC
Toxicology · 53d
Cleared Sep 05, 2003
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365 · JXM
Toxicology · 36d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000...
K023795 · JXN
Toxicology · 69d
Cleared Dec 16, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316 · DLJ
Toxicology · 74d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317 · DJR
Toxicology · 70d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · LDJ
Toxicology · 69d
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · DLJ
Toxicology · 43d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · DJG
Toxicology · 120d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041...
K020395 · DKZ
Toxicology · 118d
Cleared May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · LCM
Toxicology · 106d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031...
K020763 · DIO
Toxicology · 64d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · DLJ
Toxicology · 27d
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