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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Bence-Jones Protein
510(k) Number K972591
Device Name HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES 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 Number866.5150
Classification Product Code
JKM  
Date Received07/11/1997
Decision Date 03/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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