Device Classification Name |
calibrator, secondary
|
510(k) Number |
K032458 |
Device Name |
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT |
Applicant |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -6187
|
|
Applicant Contact |
DENISE FARMER |
Correspondent |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -6187
|
|
Correspondent Contact |
DENISE FARMER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 08/11/2003 |
Decision Date | 10/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|