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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, If, Toxoplasma Gondii
510(k) Number K880007
Device Name TOXO IGM TEST
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 Number866.3780
Classification Product Code
GLZ  
Date Received01/04/1988
Decision Date 03/17/1988
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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