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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 K854179
Device Name IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
Applicant
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Correspondent Contact ISRAEL M STEIN
Regulation Number862.1175
Classification Product Code
CHH  
Date Received10/15/1985
Decision Date 11/25/1985
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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