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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 K042270
Device Name STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
Applicant
STAT CHEM, INC.
619 NORTH POPLAR STREET
ORANGE,  CA  92868
Applicant Contact MARTIN J PATKO
Correspondent
STAT CHEM, INC.
619 NORTH POPLAR STREET
ORANGE,  CA  92868
Correspondent Contact MARTIN J PATKO
Regulation Number862.1600
Classification Product Code
CEM  
Date Received08/23/2004
Decision Date 10/06/2004
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
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