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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Cytomegalovirus
510(k) Number K853137
Device Name CMV TEST
Applicant
Gull Laboratories, Inc.
890 E. 5400 S.
Salt Lake City,  UT  84107
Applicant Contact FRED W RACHFORD
Correspondent
Gull Laboratories, Inc.
890 E. 5400 S.
Salt Lake City,  UT  84107
Correspondent Contact FRED W RACHFORD
Regulation Number866.3175
Classification Product Code
GQI  
Date Received07/26/1985
Decision Date 11/14/1985
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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