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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrophoretic, protein fractionation
510(k) Number K960029
Device Name HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
Applicant
MORAX
13805 WATERLOO RD.
CHELSEA,  MI  48118
Applicant Contact JANIK BOREK
Correspondent
MORAX
13805 WATERLOO RD.
CHELSEA,  MI  48118
Correspondent Contact JANIK BOREK
Regulation Number862.1630
Classification Product Code
CEF  
Date Received01/02/1996
Decision Date 07/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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