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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