Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K961489 |
Device Name |
ELECSYS FT4 ASSAY |
Applicant |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
P.O. BOX 4117 |
CONCORD,
CA
94524 -4117
|
|
Applicant Contact |
BETSY SOARES-MADDOX |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
P.O. BOX 4117 |
CONCORD,
CA
94524 -4117
|
|
Correspondent Contact |
BETSY SOARES-MADDOX |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/18/1996 |
Decision Date | 06/11/1996 |
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
|
|
|