Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K983417 |
Device Name |
ABBOTT ARCHITECT FREE T4 |
Applicant |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,,
IL
60064 -3537
|
|
Applicant Contact |
APRIL VEOUKAS |
Correspondent |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,,
IL
60064 -3537
|
|
Correspondent Contact |
APRIL VEOUKAS |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/29/1998 |
Decision Date | 11/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|