IMMUNICON CELLTRACKS ANALYZER


Device Classification Name

counter, differential cell

510(k) Number K030263
Device Name IMMUNICON CELLTRACKS ANALYZER
Original Applicant
IMMUNICON CORP.
3401 masons mill rd. ste 100
huntingdon valley, 
PA 
19006 -3574

Original Contact peter scott
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 01/27/2003
Decision Date 11/24/2003
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