Device Classification Name |
enzyme immunoassay, opiates
|
510(k) Number |
K181159 |
Device Name |
LZI Fentanyl Enzyme Immunoassay |
Applicant |
Lin-Zhi International, Inc. |
2945 Oakmead Village Court |
Santa Clara,
CA
95051
|
|
Applicant Contact |
Bernice Lin |
Correspondent |
Lin-Zhi International, Inc. |
2945 Oakmead Village Court |
Santa Clara,
CA
95051
|
|
Correspondent Contact |
Bernice Lin |
Regulation Number | 862.3650
|
Classification Product Code |
|
Date Received | 05/01/2018 |
Decision Date | 12/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|