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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 K820090
Device Name ASTRA-T CALCIUM REAGENT
Applicant
HI CHEM, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HI CHEM, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1145
Classification Product Code
CIC  
Date Received01/13/1982
Decision Date 01/28/1982
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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