Device Classification Name |
Enzyme Immunoassay, Cannabinoids
|
510(k) Number |
K013247 |
Device Name |
CANNABINOIDS |
Applicant |
ABBOTT LABORATORIES |
DEPT. 09VA LC-2 |
1920 HURD DRIVE |
IRVING,
TX
75038
|
|
Applicant Contact |
LINDA MORRIS |
Correspondent |
ABBOTT LABORATORIES |
DEPT. 09VA LC-2 |
1920 HURD DRIVE |
IRVING,
TX
75038
|
|
Correspondent Contact |
LINDA MORRIS |
Regulation Number | 862.3870
|
Classification Product Code |
|
Date Received | 09/28/2001 |
Decision Date | 03/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|