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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 K811748
Device Name KING DIAGNOSTICS CALCIUM TEST
Applicant
KING DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KING DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1145
Classification Product Code
CIC  
Date Received06/22/1981
Decision Date 07/10/1981
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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