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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 K842786
Device Name DYNA-LYTE 2000
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Regulation Number862.1600
Classification Product Code
CEM  
Date Received05/22/1984
Decision Date 09/14/1984
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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