Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K930322 |
Device Name |
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) |
Applicant |
HERAEUS KULZER, INC. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Applicant Contact |
GABRIEL J MURACA |
Correspondent |
HERAEUS KULZER, INC. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Correspondent Contact |
GABRIEL J MURACA |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 01/22/1993 |
Decision Date | 11/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|