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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Iha, Cytomegalovirus
510(k) Number K910003
Device Name CYTOMEGALOVIRUS ANTIBODY SCREEN
Applicant
Immucor, Inc.
3130 Gateway Dr. P.O. Box 5625
Norcross,  GA  30091
Applicant Contact RALPH A EATZ
Correspondent
Immucor, Inc.
3130 Gateway Dr. P.O. Box 5625
Norcross,  GA  30091
Correspondent Contact RALPH A EATZ
Regulation Number866.3175
Classification Product Code
LJO  
Date Received01/02/1991
Decision Date 03/20/1991
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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