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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, automated blood cell diluting
510(k) Number K040077
Device Name IMMUNICON CELLTRACKS AUTOPREP SYSTEM
Applicant
IMMUNICON CORP.
3401 MASONS MILL RD.
HUNTINGDON VALLEY,  PA  19006 -3574
Applicant Contact PETER J SCOTT
Correspondent
IMMUNICON CORP.
3401 MASONS MILL RD.
HUNTINGDON VALLEY,  PA  19006 -3574
Correspondent Contact PETER J SCOTT
Regulation Number864.5240
Classification Product Code
GKH  
Date Received01/14/2004
Decision Date 03/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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