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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number862.1600
Classification Product Code
CEM  
Date Received11/26/1991
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
Predetermined Change
Control Plan Authorized		 No
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