Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K894605 |
Device Name |
DELFIA FREE THYROXINE (FT4) KIT |
Applicant |
PHARMACIA, INC. |
800 CENTENNIAL AVE. |
PISCATAWAY,
NJ
08854 -3911
|
|
Applicant Contact |
ALBERT P MAYO |
Correspondent |
PHARMACIA, INC. |
800 CENTENNIAL AVE. |
PISCATAWAY,
NJ
08854 -3911
|
|
Correspondent Contact |
ALBERT P MAYO |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 07/20/1989 |
Decision Date | 09/18/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|