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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 K080623
Device Name CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
Applicant
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Applicant Contact SAMUEL BURGOS
Correspondent
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Correspondent Contact SAMUEL BURGOS
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
CDT  
Date Received03/05/2008
Decision Date 11/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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