Device Classification Name |
drug mixture control materials
|
510(k) Number |
K873183 |
Device Name |
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
MARY ZORC |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
MARY ZORC |
Regulation Number | 862.3280
|
Classification Product Code |
|
Date Received | 08/12/1987 |
Decision Date | 11/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|