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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 K880723
Device Name DIMENSION WHOLE BLOOD CHOLESTEROL
Applicant
Technimed, Inc.
P.O. Box 5003
4987 NW 23rd Ave.
Fort Lauderdale,  FL  33310
Applicant Contact JACK ARONOWITZ
Correspondent
Technimed, Inc.
P.O. Box 5003
4987 NW 23rd Ave.
Fort Lauderdale,  FL  33310
Correspondent Contact JACK ARONOWITZ
Regulation Number862.1175
Classification Product Code
CHH  
Date Received02/23/1988
Decision Date 11/08/1988
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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