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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Analysis, Electrophoretic Hemoglobin
510(k) Number K991362
Device Name HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
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 Number864.7440
Classification Product Code
JBD  
Subsequent Product Codes
GIQ   GKA   KQI   MLL  
Date Received04/14/1999
Decision Date 06/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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