FDA 510(k) Applications Submitted by Bernice Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110239 |
01/26/2011 |
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL |
Lin-Zhi International, Inc. |
| K110298 |
02/01/2011 |
OPIATE ENZYME IMMUNOASSAY |
Lin-Zhi International, Inc. |
| K170416 |
02/10/2017 |
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators |
Lin-Zhi International, Inc. |
| K120761 |
03/13/2012 |
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS |
Lin-Zhi International, Inc. |
| K120763 |
03/13/2012 |
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS |
Lin-Zhi International, Inc. |
| K141055 |
04/24/2014 |
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) |
Lin-Zhi International, Inc. |
| K101195 |
04/29/2010 |
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
| K181159 |
05/01/2018 |
LZI Fentanyl Enzyme Immunoassay |
Lin-Zhi International, Inc. |
| K201223 |
05/06/2020 |
LZI Tramadol Enzyme Immunoassay |
Lin-Zhi International, Inc. |
| K141205 |
05/09/2014 |
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 |
Lin-Zhi International, Inc. |
| K131652 |
06/05/2013 |
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS |
Lin-Zhi International, Inc. |
| K131653 |
06/05/2013 |
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS |
Lin-Zhi International, Inc. |
| K201938 |
07/13/2020 |
LZI Fentanyl II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
| K202007 |
07/21/2020 |
LZI Oxycodone III Enzyme Immunoassay |
Lin-Zhi International, Inc. |
| K102210 |
08/05/2010 |
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS |
Lin-Zhi International, Inc. |
| K192299 |
08/23/2019 |
LZI Cotinine II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
| K192433 |
09/05/2019 |
LZI Methadone II Enzyme Immunoassay |
Lin-Zhi International, Inc |
| K113139 |
10/24/2011 |
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS |
Lin-Zhi International, Inc. |
| K133710 |
12/04/2013 |
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS |
Lin-Zhi International, Inc. |
| K113661 |
12/13/2011 |
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS |
Lin-Zhi International, Inc. |
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