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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Cytomegalovirus
510(k) Number K935809
Device Name CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
Applicant
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact DALE DEMBRO
Correspondent
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact DALE DEMBRO
Regulation Number866.3175
Classification Product Code
GQH  
Date Received12/02/1993
Decision Date 05/05/1994
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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