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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
510(k) Number K943557
Device Name IMAGEN
Applicant
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Applicant Contact ELISABETH A JOHNSON-PROCTOR
Correspondent
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Correspondent Contact ELISABETH A JOHNSON-PROCTOR
Regulation Number866.3400
Classification Product Code
GQS  
Date Received07/22/1994
Decision Date 01/09/1995
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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