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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 28 Results
ProductCode: DLJ Applicant: Lin-Zhi International, Inc. Decision Date To: 12/09/2022
 
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lzi methadone metabolite enzyme immunoassay, lzi methadone metabolite (100 and 300) calibrators Lin-Zhi International, Inc. K170416 06/26/2017
lzi oral fluid cannabinoids enzyme immunoassay, lzi oral fluid cannabinoids calibrators and lzi oral fluid cannabinoids controls Lin-Zhi International, Inc. K141320 05/28/2015
lzi oral fluid 6-acetylmorphine enzyme immunoassay, lzi oral fluid 6-acetylmorphine calibrators (5 ml), lzi oral fluid 6 Lin-Zhi International, Inc. K141205 02/13/2015
lzi hydrocodone; enzyme immunoassay, calibrators; (5ml), (15ml); controls; (5ml), (15ml) Lin-Zhi International, Inc. K141055 06/13/2014
lzi oral fluid methamphetamine enzyme immunoassay, calibrators, controls Lin-Zhi International, Inc. K131652 03/21/2014
lzi oral fluid amphetamine enzyme immunoassay, calibrators, controls Lin-Zhi International, Inc. K131653 02/04/2014
lzi oxycodone homogeneous enzyme immunoassay, lzi oxycondone calibrators, lzi oxycodone controls Lin-Zhi International, Inc. K120763 06/01/2012
lzi opiate 2000 homogeneous enzyme immunoassay, lzi opiate 2000 calibrators, lzi opiate 2000 controls Lin-Zhi International, Inc. K120761 05/08/2012
lzi methamphetamine enzyme mmunoassay, lzi methamphetamine calibrators, lzi methamphetamine controls Lin-Zhi International, Inc. K113661 01/23/2012
lzi cocaine metabolite homogeneous enzyme immunoassay,calibrators,controls Lin-Zhi International, Inc. K113139 11/22/2011
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