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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igd, Antigen, Antiserum, Control
510(k) Number K772327
Device Name LAS-R HUMAN IGD TEST
Applicant
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5510
Classification Product Code
CZJ  
Date Received12/21/1977
Decision Date 02/28/1978
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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