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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 west olympic blvd.
los angeles,  CA  90064
Applicant Contact jay h geller
Correspondent
BIRMINGHAM
westside towers, suite 1000
11845 west 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
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