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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresolphthalein Complexone, Calcium
510(k) Number K843895
Device Name TOTAL CALCIUM REAGENT SET
Applicant
LIVONIA DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LIVONIA DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1145
Classification Product Code
CIC  
Date Received10/03/1984
Decision Date 10/30/1984
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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