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Lin-Zhi International Inc

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vit recall (Z-1270-2014)Lin-Zhi International Inc2014-03-21
Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from no recall (Z-1178-2014)Lin-Zhi International Inc2014-03-12
Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from no recall (Z-1179-2014)Lin-Zhi International Inc2014-03-12
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Di recall (Z-0386-2014)Lin-Zhi International Inc2013-11-25
Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in- recall (Z-0847-2012)Lin-Zhi International Inc2012-01-25
Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro recall (Z-0868-2012)Lin-Zhi International Inc2012-01-25
Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); recall (Z-0846-2012)Lin-Zhi International Inc2012-01-24
Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zh recall (Z-0838-2012)Lin-Zhi International Inc2012-01-23

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