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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K972015
Device Name HYDRAGEL 7,15,30, CHOL-HDL KIT
Applicant
Morax
13805 Waterloo Rd.
Chelsea,  MI  48118
Applicant Contact BOREK JANIK
Correspondent
Morax
13805 Waterloo Rd.
Chelsea,  MI  48118
Correspondent Contact BOREK JANIK
Regulation Number862.1475
Classification Product Code
LBT  
Date Received05/30/1997
Decision Date 10/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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