Device Classification Name |
Radioimmunoassay, Total Thyroxine
|
510(k) Number |
K921935 |
Device Name |
THYROXINE (T4) COATED TUBE RIA |
Applicant |
MONOBIND |
729 W. 16TH STREET, C-4 |
COSTA MESA,
CA
92627
|
|
Applicant Contact |
FREDERICK R JEROME |
Correspondent |
MONOBIND |
729 W. 16TH STREET, C-4 |
COSTA MESA,
CA
92627
|
|
Correspondent Contact |
FREDERICK R JEROME |
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 04/24/1992 |
Decision Date | 07/07/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|