| Device Classification Name |
Enzyme Immunoassay, Cannabinoids
|
| 510(k) Number |
K910893 |
| Device Name |
TARGET(TM) CANNABINOIDS-R TEST |
| Applicant |
| V-Tech, Inc. |
| 9440 Telstar Ave., Suite 7 |
|
El Monte,
CA
91731
|
|
| Applicant Contact |
WILLA K BRUNKHORST |
| Correspondent |
| V-Tech, Inc. |
| 9440 Telstar Ave., Suite 7 |
|
El Monte,
CA
91731
|
|
| Correspondent Contact |
WILLA K BRUNKHORST |
| Regulation Number | 862.3870 |
| Classification Product Code |
|
| Date Received | 03/04/1991 |
| Decision Date | 04/03/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Toxicology
|
| 510k Review Panel |
Toxicology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|