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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Peroxidase, Antigen, Antiserum, Control
510(k) Number K853607
Device Name ALLERG-E IGE ENZYME IMMUNOASSAY KIT
Applicant
Dexall Biomedical Labs, Inc.
145-4 Professional Dr.
Gaithersburg,  MD  20879
Applicant Contact THOMAS HUBSCHER
Correspondent
Dexall Biomedical Labs, Inc.
145-4 Professional Dr.
Gaithersburg,  MD  20879
Correspondent Contact THOMAS HUBSCHER
Regulation Number866.5510
Classification Product Code
DGO  
Date Received08/28/1985
Decision Date 11/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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