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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K963844
Device Name HYDRAGEL 15 HB A1C 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 Number864.7470
Classification Product Code
LCP  
Date Received09/25/1996
Decision Date 04/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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