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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 K000610
Device Name RESOLUTION CHOLESTEROL MONITOR
Applicant
Lifestream Technologies, Inc.
51o Clearwater Loop, Suite 101
Post Falls,  ID  83854
Applicant Contact JACK CONNOLLY
Correspondent
Lifestream Technologies, Inc.
51o Clearwater Loop, Suite 101
Post Falls,  ID  83854
Correspondent Contact JACK CONNOLLY
Regulation Number862.1175
Classification Product Code
CHH  
Date Received02/23/2000
Decision Date 07/21/2000
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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