FDA 510(k) Applications Submitted by CHIU CHIN CHANG

FDA 510(k) Number Submission Date Device Name Applicant
K020763 03/07/2002 COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) Lin-Zhi International, Inc.
K020769 03/07/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K023316 10/03/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc.
K023317 10/03/2002 METHADONE ENZYME IMMUNOASSAY Lin-Zhi International, Inc.
K020254 01/24/2002 PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 Lin-Zhi International, Inc.
K020368 02/04/2002 OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) Lin-Zhi International, Inc.
K020395 02/06/2002 AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) Lin-Zhi International, Inc.
K021887 06/07/2002 CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 Lin-Zhi International, Inc.
K023795 11/13/2002 PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) Lin-Zhi International, Inc.


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