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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biosensor, Immunoassay, Myoglobin
510(k) Number K981536
Device Name QUANTECH MYOGLOBIN ASSAY
Applicant
Hellen Professional Services
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
Hellen Professional Services
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number866.5680
Classification Product Code
MVE  
Date Received04/29/1998
Decision Date 06/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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