Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K112995 |
Device Name |
GEM PREMIER 4000 |
Applicant |
INSTRUMENTATION LABORATORY CO. |
526 ROUTE 303 |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
CARL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
526 ROUTE 303 |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
CARL MARBLE |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/07/2011 |
Decision Date | 05/03/2012 |
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
|
|
|