Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K121012 |
Device Name |
FLEXLAB 3.6, ACCELERATOR A3600 |
Applicant |
INPECO S.P.A. |
11 VIA G. DI VITTORIO |
SEGRATE, MILAN,
IT
20090
|
|
Applicant Contact |
ROBERTO TAMBORRA |
Correspondent |
INPECO S.P.A. |
11 VIA G. DI VITTORIO |
SEGRATE, MILAN,
IT
20090
|
|
Correspondent Contact |
ROBERTO TAMBORRA |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/03/2012 |
Decision Date | 08/31/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|