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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K792183
Device Name DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
Applicant
Dade, Baxter Travenol Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dade, Baxter Travenol Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1475
Classification Product Code
LBS  
Date Received10/29/1979
Decision Date 11/13/1979
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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