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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunosorbent Assay, T. Cruzi
510(k) Number K911233
Device Name CHAGAS' IGG ELISA TEST
Applicant
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Applicant Contact FRED W RACHFORD
Correspondent
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Correspondent Contact FRED W RACHFORD
Regulation Number866.3870
Classification Product Code
MIU  
Date Received03/20/1991
Decision Date 05/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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