Device Classification Name |
Radioimmunoassay, Total Thyroxine
|
510(k) Number |
K780219 |
Device Name |
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY |
Applicant |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 02/10/1978 |
Decision Date | 03/03/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|