Device Classification Name |
Radioimmunoassay, Thyroid-Stimulating Hormone
|
510(k) Number |
K934410 |
Device Name |
AXSYM ULTRASENSITIVE HTSH |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
D389, AP30 |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
JOY C SONSALLA |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
D389, AP30 |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
JOY C SONSALLA |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 09/10/1993 |
Decision Date | 06/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|