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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm,If, Cytomegalovirus Virus
510(k) Number K860450
Device Name THE CMV-IGM TEST
Applicant
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Applicant Contact CAROLE A GOLDEN
Correspondent
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Correspondent Contact CAROLE A GOLDEN
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received02/04/1986
Decision Date 05/13/1986
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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