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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K973954
Device Name IMAGEN RESPIRATORY SCREEN
Applicant
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Applicant Contact ELISABETH SILVER
Correspondent
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Correspondent Contact ELISABETH SILVER
Regulation Number866.3330
Classification Product Code
GNW  
Date Received10/09/1997
Decision Date 12/22/1997
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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