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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 K911692
Device Name ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
Applicant
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
355 Business Center Dr.
Horsham,  PA  19044
Applicant Contact CHRISTOPHER ZALESKY
Correspondent
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
355 Business Center Dr.
Horsham,  PA  19044
Correspondent Contact CHRISTOPHER ZALESKY
Regulation Number862.1175
Classification Product Code
CHH  
Date Received04/16/1991
Decision Date 08/16/1991
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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