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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 K973284
Device Name COBAS INTEGRA HDL-CHOLESTEROL DIRECT
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact MARIA FEIJOO
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
LBR  
Date Received09/02/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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