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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Lipoproteins
510(k) Number K974854
Device Name HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
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
JHO  
Date Received12/29/1997
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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