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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K853025
Device Name IMAGE-IGE
Applicant
Clinical Reference Laboratory, Inc.
11844 W. 85th St.
Lenexa,  KA  66214
Correspondent
Clinical Reference Laboratory, Inc.
11844 W. 85th St.
Lenexa,  KA  66214
Regulation Number866.5510
Classification Product Code
DGC  
Date Received07/18/1985
Decision Date 08/22/1985
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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