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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K897036
Device Name IMMUNOTECH CHOLESTEROL TEST
Applicant
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Applicant Contact FRANCIS E CAPITANIO
Correspondent
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Correspondent Contact FRANCIS E CAPITANIO
Regulation Number862.1175
Classification Product Code
CHH  
Date Received12/18/1989
Decision Date 03/06/1990
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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