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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 K823756
Device Name ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
Applicant
Em Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Em Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1145
Classification Product Code
CIC  
Date Received12/14/1982
Decision Date 01/12/1983
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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