Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K860252 |
Device Name |
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA |
Applicant |
AMERSHAM CORP. |
2636 SOUTH CLEARBROOK DR. |
ARLINGTON HEIGHTS,
IL
60005
|
|
Applicant Contact |
DENNIS W HENKELMAN |
Correspondent |
AMERSHAM CORP. |
2636 SOUTH CLEARBROOK DR. |
ARLINGTON HEIGHTS,
IL
60005
|
|
Correspondent Contact |
DENNIS W HENKELMAN |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 01/24/1986 |
Decision Date | 02/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|