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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
510(k) Number K911430
Device Name IDEIA(TM) CHLAMYDIA, MODIFICATION
Applicant
Novo Nordisk Diagnostics, Ltd.
Dirac House, St. John'S
Innovation Park, Cowley Rd.
Cambridge Cb4 4ws England,  GB
Applicant Contact STEPHEN A ABBOTT
Correspondent
Novo Nordisk Diagnostics, Ltd.
Dirac House, St. John'S
Innovation Park, Cowley Rd.
Cambridge Cb4 4ws England,  GB
Correspondent Contact STEPHEN A ABBOTT
Regulation Number866.3390
Classification Product Code
LIC  
Date Received03/28/1991
Decision Date 08/07/1991
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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