|
Document Number | K140748 |
Test Name | Tanner Scientific Multi-Panel Drug Test Cup |
Manufacturer Name | CO-INNOVATION BIOTECH CO.,LTD. |
Consumer Information Phone Number | (800)331-2716 |
Test Type | EDDP (methadone metabolite) |
Effective Date | 03/08/2016 |
| |
Device Classification Name |
Enzyme Immunoassay, Opiates
|
510(k) Number |
K140748 |
Device Name |
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD |
Applicant |
CO-INNOVATION BIOTECH CO.,LTD. |
No.13, Yanyuan Road, Tianhe District, |
Guangzhou,
CN
510507
|
|
Applicant Contact |
HONG FENG |
Correspondent |
CO-INNOVATION BIOTECH CO.,LTD. |
No.13, Yanyuan Road, Tianhe District, |
Guangzhou,
CN
510507
|
|
Correspondent Contact |
HONG FENG |
Regulation Number | 862.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/25/2014 |
Decision Date | 08/20/2014 |
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
|
|
|
|