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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 K855028
Device Name TOTAL CHOLESTEROL REAGENT SET
Original Applicant
STERLING DIAGNOSTICS, INC.
34210 dequindre rd.
sterling heights,  MI  48077
Original Contact david l callender
Regulation Number862.1175
Classification Product Code
CHH  
Date Received12/16/1985
Decision Date 01/28/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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