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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 K854723
Device Name SKD ELECTROCHEMICAL SYSTEM (ECS)
Applicant
SMITH KLINE DIAGNOSTICS, INC.
485 POTRERO AVE.
P.O. BOX 61947
SUNNYVALE,  CA  94086
Applicant Contact RONALD J SCHOENGOLD
Correspondent
SMITH KLINE DIAGNOSTICS, INC.
485 POTRERO AVE.
P.O. BOX 61947
SUNNYVALE,  CA  94086
Correspondent Contact RONALD J SCHOENGOLD
Regulation Number862.1600
Classification Product Code
CEM  
Date Received11/22/1985
Decision Date 03/05/1986
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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