Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K770918 |
Device Name |
LIQUI SOL T4 RIA TEST KIT |
Applicant |
DAMON CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DAMON CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1710 |
Classification Product Code |
|
Date Received | 05/19/1977 |
Decision Date | 06/17/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|