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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 K852969
Device Name ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
Applicant
Cambridge Bioscience Corp.
35 S. St.
Hopkinton,  MA  01748
Applicant Contact ROD N RAYNOVICH
Correspondent
Cambridge Bioscience Corp.
35 S. St.
Hopkinton,  MA  01748
Correspondent Contact ROD N RAYNOVICH
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received07/15/1985
Decision Date 11/05/1985
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
Recalls CDRH Recalls
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