Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K870968 |
Device Name |
TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT |
Applicant |
CANADIAN BIOCLINICAL, LTD. |
81 FINCHDENE SQUARE, |
SCARBOROUGH |
ONTARIO MIX 1B4,
CA
|
|
Applicant Contact |
JEREMY CLAPP |
Correspondent |
CANADIAN BIOCLINICAL, LTD. |
81 FINCHDENE SQUARE, |
SCARBOROUGH |
ONTARIO MIX 1B4,
CA
|
|
Correspondent Contact |
JEREMY CLAPP |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 03/10/1987 |
Decision Date | 06/22/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|