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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K932384
Device Name IDEIA(TM) ROTAVIRUS
Applicant
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Applicant Contact JOHNSON-PROCTOR
Correspondent
Dako Diagnostics , Ltd.
Denmark House, Angel Drove,
Ely
Cambridgeshire,  GB CB7 4ET
Correspondent Contact JOHNSON-PROCTOR
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received05/17/1993
Decision Date 12/27/1993
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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