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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 K841520
Device Name CMV LATEX AGGLUTINATION TEST KIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3175
Classification Product Code
LJO  
Date Received04/12/1984
Decision Date 09/07/1984
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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