Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K121468 |
Device Name |
EUROTROL GAS-ISE METABOLITES |
Applicant |
EUROTROL B.V. |
KEPLERLAAN 20 |
EDE,
NL
6716 BS
|
|
Applicant Contact |
PAUL B.P. KOOIJMANS |
Correspondent |
EUROTROL B.V. |
KEPLERLAAN 20 |
EDE,
NL
6716 BS
|
|
Correspondent Contact |
PAUL B.P. KOOIJMANS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 05/17/2012 |
Decision Date | 06/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|