Device Classification Name |
electrode, ion specific, potassium
|
510(k) Number |
K915345 |
Device Name |
STAT K SYSTEM |
Applicant |
PORTABLE DIAGNOSTIC SERVICES, INC. |
2260 TOWNSGATE RD. |
SUITE 2 |
WESTLAKE VILLAGE,
CA
91361
|
|
Applicant Contact |
GERARD J PUTZ |
Correspondent |
PORTABLE DIAGNOSTIC SERVICES, INC. |
2260 TOWNSGATE RD. |
SUITE 2 |
WESTLAKE VILLAGE,
CA
91361
|
|
Correspondent Contact |
GERARD J PUTZ |
Regulation Number | 862.1600
|
Classification Product Code |
|
Date Received | 11/26/1991 |
Decision Date | 07/16/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|