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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, (Chlamydiae Group)
510(k) Number K901972
Device Name ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
Applicant
Novo Nordisk Diagnostics, Ltd.
Dirac House, St. John'S
Innovation Park, Cowley Rd.
Cambridge Cb4 4ws England,  GB
Applicant Contact R ABBOTT,PHD
Correspondent
Novo Nordisk Diagnostics, Ltd.
Dirac House, St. John'S
Innovation Park, Cowley Rd.
Cambridge Cb4 4ws England,  GB
Correspondent Contact R ABBOTT,PHD
Regulation Number866.3120
Classification Product Code
LJC  
Date Received05/01/1990
Decision Date 09/05/1990
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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