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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 K896073
Device Name CHOLESTEROL, UNIVERSAL ET
Applicant
Enzyme Technology, Inc.
427-3 Amherst St., Suite 132
Nashua,  NH  03063
Applicant Contact PETER R KLAMKA
Correspondent
Enzyme Technology, Inc.
427-3 Amherst St., Suite 132
Nashua,  NH  03063
Correspondent Contact PETER R KLAMKA
Regulation Number862.1175
Classification Product Code
CHH  
Date Received10/19/1989
Decision Date 12/12/1989
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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