CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518


Device Classification Name

apparatus, automated blood cell diluting

510(k) Number K022512
Device Name CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
Original Applicant
IMMUNICON CORP.
3401 masons mill rd. ste 100
huntingdon valley, 
PA 
19006 -3574

Original Contact peter scott
Regulation Number 864.5240
Classification Product Code
GKH  
Date Received 07/30/2002
Decision Date 09/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No