Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K771236 |
Device Name |
TRIOBEAD-125 DIAGNOSTIC KIT |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 07/11/1977 |
Decision Date | 08/03/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|