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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 K952490
Device Name IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
Applicant
Roche Image Analysis Systems
112 Orange Dr.
Elon College,  NC  27244
Applicant Contact ROLLIN HEINZERLING
Correspondent
Roche Image Analysis Systems
112 Orange Dr.
Elon College,  NC  27244
Correspondent Contact ROLLIN HEINZERLING
Regulation Number866.5100
Classification Product Code
LJM  
Date Received05/30/1995
Decision Date 12/15/1995
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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