IMMUNICON CELLSAVE PRESERVATIVE TUBE


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K030596
Device Name IMMUNICON CELLSAVE PRESERVATIVE TUBE
Applicant
IMMUNICON CORP.
3401 masons mill rd. ste 100
huntingdon valley, 
PA 
19006 -3574

Applicant Contact peter scott
Correspondent
IMMUNICON CORP.
3401 masons mill rd. ste 100
huntingdon valley, 
PA 
19006 -3574

Correspodent Contact peter scott
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 02/25/2003
Decision Date 08/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No