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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 Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K900796
Device Name CMV IGG ELISA 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 Number866.3175
Classification Product Code
LFZ  
Date Received02/20/1990
Decision Date 05/02/1990
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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