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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 15 Results
ProductCode: DJG Applicant: Lin-Zhi International, Inc. Decision Date To: 05/05/2024
 
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lzi oxycodone iii enzyme immunoassay Lin-Zhi International, Inc. K202007 09/17/2020
lzi fentanyl ii enzyme immunoassay Lin-Zhi International, Inc. K201938 08/07/2020
lzi tramadol enzyme immunoassay Lin-Zhi International, Inc. K201223 06/04/2020
lzi fentanyl enzyme immunoassay Lin-Zhi International, Inc. K181159 12/03/2018
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 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
opiate enzyme immunoassay Lin-Zhi International, Inc. K110298 07/15/2011
6-acetylmorphine enzyme immunoassay with 6-acetylmorphine calibrators and controls Lin-Zhi International, Inc. K101195 07/06/2010
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