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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Antigen, Antiserum, Control
510(k) Number K875356
Device Name IMMUNOGLOBULIN G & G SUBCLASSES
Applicant
Birmingham
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
Birmingham
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number866.5510
Classification Product Code
DEW  
Date Received12/31/1987
Decision Date 02/10/1988
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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