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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 K872968
Device Name ULTRASCAN IGE ASSAY KIT
Applicant
Specialty Medical Industries, Inc.
13071 Brookhurst, Suite 185
Garden Grove,  CA  92643
Applicant Contact MICHAEL BELL
Correspondent
Specialty Medical Industries, Inc.
13071 Brookhurst, Suite 185
Garden Grove,  CA  92643
Correspondent Contact MICHAEL BELL
Regulation Number866.5510
Classification Product Code
DGC  
Date Received07/29/1987
Decision Date 08/28/1987
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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