Device Classification Name |
radioimmunoassay, total thyroxine
|
510(k) Number |
K761272 |
Device Name |
CENTRIA T4 RIA |
Applicant |
CLINICAL DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CLINICAL DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 12/20/1976 |
Decision Date | 03/16/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|