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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 K831987
Device Name EPSILON IGE TEST KIT
Applicant
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
DGO  
Date Received06/21/1983
Decision Date 10/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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