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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 K974901
Device Name HYBRID CAPTURE SYSTEM CMV DNA ASSAY
Applicant
Digene Corp.
9000 Virginia Manor Rd.,
Beltsville,  MD  20705
Applicant Contact CONSTANCE A FINCH
Correspondent
Digene Corp.
9000 Virginia Manor Rd.,
Beltsville,  MD  20705
Correspondent Contact CONSTANCE A FINCH
Regulation Number866.3175
Classification Product Code
LJO  
Date Received12/31/1997
Decision Date 09/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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