FDA 510(k) Applications Submitted by CHENG KO LIN

FDA 510(k) Number Submission Date Device Name Applicant
K032461 08/11/2003 ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 Lin-Zhi International, Inc.
K970795 03/04/1997 SHANG HO SHANG HO INDUSTRIAL CORP. LTD.
K964819 12/02/1996 SHENG HO SHANG HO INDUSTRIAL CORP. LTD.
K050733 03/17/2005 OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K050945 04/14/2005 ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS Lin-Zhi International, Inc.
K051058 04/26/2005 METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K051088 04/28/2005 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K031797 06/10/2003 METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) Lin-Zhi International, Inc.
K032365 07/31/2003 BENZODIAZEPINE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K032764 09/05/2003 BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) Lin-Zhi International, Inc.
K033094 09/29/2003 ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) Lin-Zhi International, Inc.
K033866 12/12/2003 CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) Lin-Zhi International, Inc.
K033885 12/15/2003 BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) Lin-Zhi International, Inc.
K183041 11/01/2018 Full Digital Colour Doppler Ultrasonic Diagnostic System Wuhan Zoncare Bio-medical Electronics Co., Ltd
K181870 07/12/2018 Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use Wuhan W.E.O Science & Technology Development Co., Ltd.


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