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Lin-Zhi International, Inc.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253082 LZI Buprenorphine II Enzyme ImmunoassayDJG2026-01-16 View
510(k) K251634 LZI Fentanyl III Enzyme ImmunoassayDJG2025-06-18 View
510(k) K202007 LZI Oxycodone III Enzyme ImmunoassayDJG2020-09-17 View
510(k) K201938 LZI Fentanyl II Enzyme ImmunoassayDJG2020-08-07 View
510(k) K201223 LZI Tramadol Enzyme ImmunoassayDJG2020-06-04 View
510(k) K192299 LZI Cotinine II Enzyme ImmunoassayMKU2019-11-21 View
510(k) K192433 LZI Methadone II Enzyme ImmunoassayDJR2019-10-04 View
510(k) K181159 LZI Fentanyl Enzyme ImmunoassayDJG2018-12-03 View
510(k) K170416 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsDJR2017-06-26 View
510(k) K120763 LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01 View
510(k) K120761 LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLSDJG2012-05-08 View
510(k) K113661 LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23 View
510(k) K113139 LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22 View
510(k) K110298 OPIATE ENZYME IMMUNOASSAYDJG2011-07-15 View
510(k) K110239 LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23 View
510(k) K102210 LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSDKZ2010-12-28 View
510(k) K101195 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06 View
510(k) K090844 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30 View
510(k) K081008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMSDJG2008-12-22 View
510(k) K063024 LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLSDKZ2006-10-30 View
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