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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 K902098
Device Name CHOLESTEROL (RATE) REAGENT
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact MATHEW MADAPPALLY
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact MATHEW MADAPPALLY
Regulation Number862.1175
Classification Product Code
CHH  
Date Received05/08/1990
Decision Date 08/09/1990
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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