Device Classification Name |
radioimmunoassay, thyroxine-binding globulin
|
510(k) Number |
K874658 |
Device Name |
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) |
Applicant |
TECHNICON INSTRUMENTS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
LEONARD A DWARICA |
Correspondent |
TECHNICON INSTRUMENTS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
LEONARD A DWARICA |
Regulation Number | 862.1685
|
Classification Product Code |
|
Date Received | 11/12/1987 |
Decision Date | 12/18/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|