Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K853703 |
Device Name |
VENTREZYME T3 IMMUNOASSAY T3 |
Applicant |
VXR, INC. |
217 READ ST. |
PORTLAND,
ME
04103
|
|
Applicant Contact |
JAMES W CHAMPLIN |
Correspondent |
VXR, INC. |
217 READ ST. |
PORTLAND,
ME
04103
|
|
Correspondent Contact |
JAMES W CHAMPLIN |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 09/04/1985 |
Decision Date | 10/04/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|