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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
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