Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K896222 |
Device Name |
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
P.O. BOX 92797 |
LOS ANGELES,
CA
90009
|
|
Applicant Contact |
SANDRA MORRIS |
Correspondent |
NICHOLS INSTITUTE DIAGNOSTICS |
P.O. BOX 92797 |
LOS ANGELES,
CA
90009
|
|
Correspondent Contact |
SANDRA MORRIS |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 10/30/1989 |
Decision Date | 11/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|