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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
510(k) Number K031363
Device Name QCA (VERSION 3.1)
Applicant
CELL ANALYSIS, INC.
1801 MAPLE AVENUE
SUTIE 2319
EVANSTON,  IL  60202
Applicant Contact JOEL HERM
Correspondent
CELL ANALYSIS, INC.
1801 MAPLE AVENUE
SUTIE 2319
EVANSTON,  IL  60202
Correspondent Contact JOEL HERM
Regulation Number864.1860
Classification Product Code
NQN  
Date Received04/30/2003
Decision Date 02/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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