|
Document Number | K133968 |
Test Name | Jant Pharmacal Corporation Accutest Multi-Drug Urine Test Cup |
Manufacturer Name | Guangzhou Wondfo Biotech Co., Ltd. |
Consumer Information Phone Number | 1(800)676-5565 |
Test Type | Cannabinoids (THC) |
Effective Date | 10/22/2015 |
| |
Device Classification Name |
Enzyme Immunoassay, Amphetamine
|
510(k) Number |
K133968 |
Device Name |
WONDFO MULTI-DRUG URINE TEST CUP, PANEL |
Applicant |
Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. |
SUITE F |
GAITHERSBURG,
MD
20878
|
|
Applicant Contact |
Joe Shia |
Correspondent |
Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE. |
SUITE F |
GAITHERSBURG,
MD
20878
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3100
|
Classification Product Code |
|
Date Received | 12/26/2013 |
Decision Date | 02/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|
|