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Lin-Zhi International, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2026-01-16
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
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