FDA 510(k) Applications Submitted by CHENG-I LIN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
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