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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Adenovirus 1-33
510(k) Number K922801
Device Name RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
Applicant
Light Diagnostics
27520 Enterprise Cir. W.
Temecula,  CA  92390
Applicant Contact DALE DEMBROW
Correspondent
Light Diagnostics
27520 Enterprise Cir. W.
Temecula,  CA  92390
Correspondent Contact DALE DEMBROW
Regulation Number866.3020
Classification Product Code
GNY  
Date Received06/10/1992
Decision Date 01/06/1993
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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