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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 K875254
Device Name GULLSORB IGG INACTIVATION REAGENT
Applicant
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Applicant Contact RACHFORD, PHD
Correspondent
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Correspondent Contact RACHFORD, PHD
Regulation Number866.5510
Classification Product Code
DEW  
Date Received12/22/1987
Decision Date 02/17/1988
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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