Device Classification Name |
radioimmunoassay, total triiodothyronine
|
510(k) Number |
K881214 |
Device Name |
IMMPULSE T, ASSAY REAGENTS |
Applicant |
SCLAVO, INC. |
1240 ELKO DR. |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
MICHAEL BRINKLEY |
Correspondent |
SCLAVO, INC. |
1240 ELKO DR. |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
MICHAEL BRINKLEY |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 03/21/1988 |
Decision Date | 05/27/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|