| Device Classification Name |
Enzyme Immunoassay, Cannabinoids
|
| 510(k) Number |
K871695 |
| Device Name |
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5 |
| Applicant |
| Diagnostic Products Corp. |
| 5700 W. 96th St. |
|
Los Angeles,
CA
90045 -5597
|
|
| Applicant Contact |
PAUL DURHAM |
| Correspondent |
| Diagnostic Products Corp. |
| 5700 W. 96th St. |
|
Los Angeles,
CA
90045 -5597
|
|
| Correspondent Contact |
PAUL DURHAM |
| Regulation Number | 862.3870 |
| Classification Product Code |
|
| Date Received | 04/30/1987 |
| Decision Date | 06/05/1987 |
| 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
|
|
|