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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K940700
Device Name AUTOZYME SCREEN
Applicant
Cambridge Life Sciences Plc.
Cambridgeshire Business Park
Angel Drove
Ely, Cambridgeshire,  GB CB7 4DT
Applicant Contact R BARBER
Correspondent
Cambridge Life Sciences Plc.
Cambridgeshire Business Park
Angel Drove
Ely, Cambridgeshire,  GB CB7 4DT
Correspondent Contact R BARBER
Regulation Number866.5100
Classification Product Code
LJM  
Date Received02/16/1994
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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