Device Classification Name |
fluorescence polarization immunoassay, carbamazepine
|
510(k) Number |
K940682 |
Device Name |
AXSYM(TM) QUINIDINE |
Applicant |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
KATHY ZENG |
Correspondent |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
KATHY ZENG |
Regulation Number | 862.3645
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/10/1994 |
Decision Date | 06/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|