|
Document Number | K143599 |
Test Name | Chemtron Biotech, Inc. Chemtrue Drug Screen Cup Tests with OPI 2000 |
Manufacturer Name | Chemtron Biotech, Inc. |
Consumer Information Phone Number | (858)450-0044 |
Test Type | Phencyclidine (PCP) |
Effective Date | 04/20/2015 |
| |
Device Classification Name |
enzyme immunoassay, opiates
|
510(k) Number |
K143599 |
Device Name |
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 |
Applicant |
Chemtron Biotech, Inc. |
9245 Brown Deer Road |
San Diego,
CA
92121
|
|
Applicant Contact |
Jane Zhang |
Correspondent |
Chemtron Biotech, Inc. |
9245 Brown Deer Road |
San Diego,
CA
92121
|
|
Correspondent Contact |
Jane Zhang |
Regulation Number | 862.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/18/2014 |
Decision Date | 04/17/2015 |
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
|
|
|
|