Device Classification Name |
Radioimmunoassay, Total Thyroxine
|
510(k) Number |
K823265 |
Device Name |
MONOCLONAL ANTIBODY T4 RADIO-KIT |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 11/02/1982 |
Decision Date | 12/09/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|