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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
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