Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K121759 |
Device Name |
CONE-TROL LIQUID CHEMISTRY CONTROLS |
Applicant |
CONE BIOPRODUCTS |
1012 N Austin St |
SEGUIN,
TX
78155
|
|
Applicant Contact |
WILL CONE |
Correspondent |
CONE BIOPRODUCTS |
1012 N Austin St |
SEGUIN,
TX
78155
|
|
Correspondent Contact |
WILL CONE |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 07/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|