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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 K844044
Device Name LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
Applicant
Medica Corp.
183 Walnut St.
Newtonville,  MA  02160
Applicant Contact PATRICIA S MCCARTHY
Correspondent
Medica Corp.
183 Walnut St.
Newtonville,  MA  02160
Correspondent Contact PATRICIA S MCCARTHY
Regulation Number862.1600
Classification Product Code
CEM  
Date Received10/17/1984
Decision Date 11/27/1984
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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