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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K922241
Device Name AUTOZYME
Applicant
Cambridge Life Sciences Plc.
55 Northern Blvd.
Suite 301
Great Neck,  NY  11201
Applicant Contact ANAND AKERKAR
Correspondent
Cambridge Life Sciences Plc.
55 Northern Blvd.
Suite 301
Great Neck,  NY  11201
Correspondent Contact ANAND AKERKAR
Regulation Number866.5100
Classification Product Code
LLL  
Date Received05/13/1992
Decision Date 11/30/1992
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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